araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of MK2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (2206-015)

Summary: This study will find the maximum tolerated dose of MK2206 in combination with both trastuzumab and trastuzumab/lapatinib in patients with HER2+ breast cancer and other solid tumors.


Eligibility: Inclusion Criteria:
  -  Patient has a histologically or cytologically-confirmed locally advanced or metastatic HER2+ solid tumor
  -  Female patients have a negative pregnancy test
  -  Patient is able to swallow tablets
  Exclusion Criteria:
  -  Patient has had chemotherapy, radiotherapy or biological therapy within 4 weeks of screening. Patients who were receiving trastuzumab and/or lapatinib prior to screening must be off both medications for 1 week prior to first dose of MK2206 if trastuzumab had been administered at 2 mg/kg weekly and 3 weeks if trastuzumab had been administered at 6 mg/kg weekly
  -  Patient has primary CNS tumor or known active CNS metastases
  -  Patient has a history or evidence of heart disease
  -  Patient has poorly controlled high blood pressure or diabetes
  -  Patient is pregnant or breastfeeding or is expecting to conceive or father children during the study
  -  Patient is HIV positive

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Using Video Images to Improve Advance Care Planning in Patients With Cancer

Summary: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone.

Detailed description: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone. Subjects will choose among three goals of care, life prolonging care, basic medical care, and comfort care.

Eligibility: Inclusion Criteria:
  1. Terminal, progressive cancer with poor prognosis whose treatment intent is palliative, based on the following definition:
  -  All patients with brain cancer, liver cancer, inoperable non-small cell lung carcinoma, pancreatic cancer, or gallbladder cancer; OR
  -  Patients with the following cancers: metastatic colon cancer or stage III or IV non-small cell lung cancer; OR
  -  Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, stomach cancer, esophageal cancer, melanoma, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma.
  -  The terms terminal, progressive, poor prognosis, palliative intent and limited response will be judged by the patient's oncologist (and not by the RSA or consenting professional).
  2. Return patient visit (defined as a patient known to the oncologist from previous assessments and treatments, where the working and personal relationship has been established and not a new patient to the clinic).
  3. English speaking. Only English-speaking patients will be included in our present study since English is the validated language of our study tools.
  4. Given the sensitive nature of the study, clinicians will decide whether the patient is a potentially appropriate subject based on their knowledge of the patient.
  5. Able to provide informed consent.
  6. Age greater than or equal to 21.
  Exclusion Criteria:
  1. MMSE < 25.
  2. Psychological state not appropriate for end-of-life discussion as determined by the treating clinician.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804

Summary: This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.

Detailed description: The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue.

Eligibility: Inclusion Criteria:
  -  Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
  -  Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.
  Exclusion Criteria:
  -  Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
  -  Prior or concurrent radiation therapy to tumor at site of planned resection.
  -  Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant ventricular arrythmia.
  -  Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
  -  Prior or concurrent radiation therapy to tumor at site of planned resection.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: DNA Chip Based Prognosis of Lung Cancer

Summary: The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).


Eligibility: Inclusion Criteria:
  1. A histological diagnosis of primary NSCLC stage Ia
  2. Surgical removal of the tumor
  3. Age between 18 and 75 years
  4. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
  2. Adjuvant treatment with chemotherapy.
  3. Prior history of cancer in the past 5 years or breast cancer at any time.
  4. Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
  Secondary
  -  To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
  OUTLINE: This is a multicenter study.
  Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following advanced metastatic malignancies:
  -  Malignant melanoma
  -  Lung cancer
  -  Breast cancer
  -  Pancreatic carcinoma
  -  Colorectal cancer
  -  Advanced and/or metastatic disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.


Eligibility: Inclusion Criteria:
  -  Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Contraception.
  -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  -  For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
  -  History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
  -  Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
  -  History or current evidence of cardiac arrhythmia and/or conduction abnormality
  -  Women who are pregnant or nursing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer

Summary: This study will examine the potential for an Interactive Cancer Communication System (ICCS) to impact not only psychosocial outcomes such as quality of life but also length of survival in an advanced stage lung cancer population. Two hypotheses will be tested: the Comprehensive Health Enhancement Support System- Lung Cancer (CHESS- LC) will significantly improve patient quality of life and length of overall survival as compared to a usual care control group.

Detailed description: The prognosis for Non-Small Cell Lung Cancer patients remains poor despite recent advances in anti-cancer therapies. A lung cancer diagnosis often inflicts fear, despair, and hopelessness on patients and loved ones. For lung cancer patients in particular, a population where palliation rather than cure is often the focus, interventions addressing communication about various types of suffering are crucial to quality of life (QOL). Our Center has done extensive research testing CHESS (Comprehensive Health Enhancement Support System), a non-commercial, web-based information and support system. The recent Clinician Integration Project tested the impact of CHESS versus an Internet only Control group on QOL for caregivers of advanced stage lung cancer patients. This study yielded an unanticipated finding that CHESS may have a survival benefit for patients as one year survival was significantly increased in the CHESS group (50%) compared to Internet (34.2%). As this project did not focus on patient outcomes, follow-up with a well-formulated study designed and powered to address specific hypotheses of the nature of this effect is critical. The proposed study will specifically test QOL and survival effects of CHESS on lung cancer patients. Using sites in Wisconsin, Connecticut,Houston, and Chicago, we will randomly assign 376 advanced lung cancer patients to two study arms: a patient control group receiving Usual Care (including access to a computer and Internet) and a group given access to the CHESS website. Patients may invite a caregiver to participate. Patients will be followed for 18 months or until patient death.

Eligibility: Inclusion Criteria:
  -  All patients must be diagnosed with non-small cell lung cancer (Stage IIIA non surgical, IIIB or IV)
  -  All patients must be within 12 months of their primary lung cancer diagnosis or metastatic or recurrence disease.
  -  All patients must be at least 18 years of age,
  -  All patients must have an ECOG Performance Status rating of level 0, 1 or 2.
  -  If patients have brain metastases, they must be stable
  -  All patients must be under the care of a clinician who has consented to participate in the study.
  -  All patients must be able to speak and read English (educational attainment of at least 6th grade).
  -  All patients will be invited to have a caregiver also participate in the study, however this is not required.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Summary: This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

Detailed description: PRIMARY OBJECTIVE:
  I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.
  OUTLINE:
  Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

Eligibility: Inclusion Criteria:
  Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy Ability to understand and the willingness to sign a written informed consent document
  Exclusion Criteria:
  Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy other than brain irradiation for brain metastases

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

Summary: The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.


Eligibility: Inclusion Criteria:
  -  Small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer
  -  Patients with UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
  -  Patients to receiving CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
  Exclusion Criteria:
  -  Contraindication of CPT-11
  -  ECOG PS 3-4

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Established Lung Cancer Cell Line and Stroma Cell From Surgical Tissue

Summary: Try to find lung cancer stem cells from primary culture of routine surgical resection of lung cancer tissue including cancer cells and stroma cells, then characterization the established cell lines, and compare the difference of stroma cells between tumor part and surrounding part.


Eligibility: Inclusion Criteria:
  -  lung cancer patient with surgical resection of lung tumor
  Exclusion Criteria:
  -  lung cancer patient without surgical resection of lung tumor

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Breast Cancer With Over-expression of erbB2-BRAINSTORM

Summary: This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.


Eligibility: Inclusion Criteria:
  1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
  2. Brain metastasis diagnosis made between January 2006 - December 2008.
  Exclusion Criteria:
  1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
  2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study

Summary: The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.

Detailed description: Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.

Eligibility: Inclusion Criteria:
  -  Age > 18 years
  -  Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings
  -  Suspected involvement of mediastinal lymph nodes on CT-PET scan
  -  Written informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

Summary: The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.

Detailed description: Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.

Eligibility: Inclusion Criteria:
  1. Patients with histologically or cytologically confirmed small cell lung cancer
  2. Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment.
  3. Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.
  4. Patient with asymptomatic or treated brain metastasis.
  5. Patients without current concomitant chemotherapy
  6. Patients without current concomitant radiotherapy
  7. Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.
  8. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  9. Patients aged 18 years or older
  10. ECOG performance status 0-2
  11. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; hemoglobin > 9g/dL; -; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min.
  12. Patients who signed and dated the informed consent form prior to specific study procedures.
  13. Patients who can comply with the scheduled follow-up and toxicity management procedure.'
  Exclusion Criteria:
  1. Patients with history of treatment with mTOR inhibitors
  2. Pregnant with gastrointestinal problem impairing absorption of drugs
  3. Patients who could not use appropriate method of contraception
  4. Pregnant or feeding patients
  5. Other medically ill patients
  6. Severe heart/pulmonary disease
  7. DM patients
  8. Other malignancy except cured skin cancer or uterine cervix carcinoma in situ
  9. High cholesterolemia greater than grade 3
  10. Patients with symptomatic brain metastasis
  11. Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)
  12. Patients receiving immunosuppressant

Relevance to patient case: not relevant