araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Summary: This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Detailed description: PRIMARY OBJECTIVES:
  I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
  SECONDARY OBJECTIVES:
  I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
  OUTLINE: Patients are randomized to 1 of 2 arms.
  ARM A: Patients receive usual care.
  ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
  After completion of study, patients are followed up for 6 months.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed patients for the following conditions
  -  Colon cancer stage III and IV
  -  Rectal cancer stage II, III, IV
  -  Glioblastoma multiforme (brain) -- no stage
  -  Non-small cell lung cancer stage IIIA, IIIB, IV
  -  Small cell lung cancer, limited stage and extensive stage
  -  Castration-resistant prostate cancer
  -  Head and neck cancer stage III and IV
  -  Gastric cancer stage III and IV
  -  Esophageal cancer stage III and IV
  -  Pancreatic cancer stage II, III, IV
  -  Renal cell carcinoma, stage IV
  -  Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
  -  Sarcoma, stage IV
  -  Bladder carcinoma, stage IV
  -  Acute myeloid leukemia
  -  Melanoma, stage III and IV
  -  Ovarian cancer, stage III and IV
  -  High grade myelodysplastic syndrome (MDS)
  -  Any patient with recurrent or progressive cancer
  -  Patients must have the ability to understand and willingness to sign a written informed consent document
  -  Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
  Exclusion Criteria:
  -  Patients must have capacity to consent
  -  Pregnant patients are excluded

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Phase II Trial of AZD2014 in RICTOR Amplified Solid Cancer Patients Refractory to Standard Chemotherapy

Summary: Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.
  Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Detailed description: Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.
  Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).
  Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.
  If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.
  Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of treatment, will be collected.

Eligibility: Inclusion Criteria:
  1. Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy.
  - Rare cancers are defined as sarcoma, neuroendocrine carcinoma
  2. Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy)
  3. Patients with RICTOR amplification through NGS.
  4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  Exclusion Criteria:
  1. Patients not having received recommended treatment-lines and chemotherapy regimen for the treatment of each tumor type in the advanced setting.
  2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
  3. HER2 positive AGC patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Summary: The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed description: Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility: Inclusion Criteria:
  -  Brazilian patients with metastatic non-small cell lung cancer.
  Exclusion Criteria:
  -  Small cell lung cancer and non-metastatic patients.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: HER2/Mesothelin/Lewis-Y/PSCA/MUC1/PD-L1/CD80/86-CAR-T Cells Immunotherapy Against Cancers

Summary: The third generation of CAR-T cells that target HER2, Mesothelin, Lewis-Y, PSCA, MUC1, PD-L1, or CD80/86 have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with HER2, Mesothelin, Lewis-Y, PSCA, MUC1, PD-L1 expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the HER2/Mesothelin/Lewis-Y/PSCA/MUC1/PD-L1/CD80/86-CAR-T cell immunotherapy on human cancers will firstly be tested.

Detailed description: 1. Choose appropriate patients with advanced lung or other cancers,with written consent for this study;
  2. Perform biopsy to determine the expression of HER2, Mesothelin, Lewis-Y, PSCA, MUC1, or PD-L1 of the tumor by western blotting or IHC;
  3. Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with HER2, Mesothelin, Lewis-Y, PSCA, MUC1, PD-L1, or CD80/86 targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as needed;
  4. Evaluate the clinical results as needed.

Eligibility: Inclusion Criteria:
  1. Patients with advanced cancer that expresses PSCA, MUC1, PD-L1, and/or CD80/86 protein; 2. Life expectancy >12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of PSCA, MUC1, PD-L1, or CD80/86 CAR determined by flow-cytometry and killing of PSCA,MUC1,PD-L1,or CD80/86-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
  -
  Exclusion Criteria:
  1. Had accepted gene therapy before;
  2. Severe virus infection such as HBV,HCV,HIV,et al;
  3. Known HIV positivity;
  4. Active infectious disease related to bacteria, virus,fungi,et al;
  5. Other severe diseases that the investigators consider not appropriate;
  6. Pregnant or lactating women;
  7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
  8. Other conditions that the investigators consider not appropriate. -

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites

Summary: This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.

Detailed description: As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.

Eligibility: Inclusion Criteria:
  -  18 and ≤ 80 years of age
  -  Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited
  -  Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months
  -  The hematopoietic function of bone marrow was normal without bleeding tendency (INR < 1.5), blood routine examination: HGB ≥ 90 g/L, WBC > 4.0 × 10^9/L (NEU ≥ 1.5 × 10^9/L), PLT ≥ 80 × 10^9/L
  -  Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN
  -  Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min
  -  ECG and blood glucose level were normal
  -  Patients or family members agreed to participate in the study and signed informed consent
  -  No other serious heart and lung disease, etc.
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Allergic constitution and multi-drug allergy
  -  Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction
  -  Concurrent severe infection
  -  HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)
  -  Cognitive impairment or poor chemotherapy compliance determined by investigator
  -  Less than 4 weeks from the last clinical trial
  -  Unsuitable for clinical trials determined by investigator

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Efficacy and Safety of Targeted Precision Therapy in Refractory Tumor With Druggable Molecular Event

Summary: This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

Detailed description: The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. The efficacy and safety of targeted drug were evaluated.

Eligibility: Inclusion Criteria:
  -  Malignant solid tumors diagnosed histologically;
  -  Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment;
  -  Expected survival ≥ 1 month;
  -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
  Exclusion Criteria:
  -  Patient still has standard treatment therapy based on NCCN guidance;
  -  Patient can not comply with research program requirements or follow-up;

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Increasing Colorectal and Breast Cancer Screening in Women

Summary: This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:
  1. usual care;
  2. a TIWeb (tailored intervention Website)
  3. a CSC (cancer screening call) and
  4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.

Detailed description: This study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the United States.The cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. This research tests intervention to simultaneously increase both CRC and BC screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to BC & CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.

Eligibility: Inclusion Criteria:
  -  a patient of any of the participating physicians
  -  not having had a fecal occult blood test (fobt) in the last 12 months
  -  not having had a fecal immunochemical test (fit) in the past 15 months
  -  not having had sigmoidoscopy more than 5 years ago
  -  not having had a colonoscopy more than 10 years ago
  -  have high-speed internet access
  Exclusion Criteria
  -  a personal history of colorectal cancer
  -  a personal history of breast cancer
  -  a personal history of colorectal polyps
  -  a personal history of inflammatory bowel disease
  -  having any medical conditions that would prohibit a mammogram or CRC screening
  -  have already had CRC screening

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)

Summary: The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer

Detailed description: The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity. The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers. The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed equestionnaire.
  Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Eligibility: Inclusion Criteria:
  -  Able to provide written informed consent
  -  Histologically confirmed diagnosis of colon carcinoma
  -  CT or MRI verified as T4 colon cancer without involvement of other organs
  -  Without multiple lesion other than carcinoma in situ
  -  Tumor size < 8 cm
  -  No bowel obstruction
  -  Sufficient organ function
  -  No history of gastrointestinal surgery
  -  18 years of age or older
  -  Performance Status (ECOG) 0, 1 or 2 and life expectancy > 12 weeks
  -  Operable patients
  Exclusion Criteria:
  -  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  -  Unstable or uncompensated respiratory or cardiac disease
  -  Serious active infections
  -  Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  -  Stomatitis, ulceration in the mouth or gastrointestinal tract
  -  Severe diarrhea
  -  Peripheral sensory neuropathy with functional impairment

Relevance to patient case: not relevant