araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Lifestyle Intervention for Breast Cancer Survivors

Summary: 1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment.
  2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.

Detailed description: Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors.
  All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up.
  If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.

Eligibility: Inclusion Criteria:
  -  First diagnosed with breast cancer in the past 1.5 years
  -  stage 0~2 breast cancer
  -  no prior adjuvant treatment for another cancer
  -  Can read and write English
  -  Are not participating in other health behavior research right now
  Exclusion Criteria:
  -  apparent serious mental disturbance
  -  male breast cancer survivors

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Web-based Screening and Tailored Support

Summary: The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.


Eligibility: Inclusion Criteria:
  -  Adult female breast cancer patients (aged ≥ 18 years of age).
  -  Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
  -  Ability to comprehend Dutch (both reading and writing).
  -  Access to internet (e.g. at home, via family or friends)
  -  Informed consent provided
  Exclusion Criteria:
  • Chemotherapy treatment with palliative intent or recurrent breast cancer

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

Summary: This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

Detailed description: Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. Currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. There is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. Ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. This study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. The innovative online decision tool has been developed and tested over the past two years by the CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our Communication and Dissemination Core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.

Eligibility: Inclusion Criteria:
  -  Stage 1-2 invasive breast cancer diagnosis,
  -  DCIS
  -  Ability to read English
  Exclusion Criteria:
  -  Male

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Summary: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Detailed description: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Eligibility: Inclusion Criteria:
  Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression
  Exclusion criteria:
  Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy

Summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
  2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
  3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
  4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed with malignant tumor and malignant cavity effusion.
  2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
  3. Normal cardiac, hepatic, renal and bone marrow functions.
  4. Life expectancy >3 months.
  5. Not receive other anti-tumor treatment.
  6. Not receive chemotherapy in pleural and abdominal cavity.
  Exclusion Criteria:
  1. Previous history of other malignancies.
  2. Serious or uncontrolled concurrent medical illness.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Real World Efficiency of Trastuzumab in Early Breast Cancer

Summary: AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
  RESEARCH QUESTIONS / OBJECTIVES
  1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
  2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?
  To address the research questions (objectives), the following outcome measures will be determined:
  CLINICAL OUTCOME MEASURES
  1. Actual trastuzumab administration as opposed to planned trastuzumab administration
  2. Selection criteria for chemotherapy and trastuzumab in daily practice
  3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
  4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab
  ECONOMIC OUTCOME MEASURES
  5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
  6. Cost-effectiveness of trastuzumab in clinical trials versus in real world


Eligibility: Inclusion Criteria:
  -  All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.
  Exclusion Criteria:
  -  Distant metastasis at the time of the primary diagnosis

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

Summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
  2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
  3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
  4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
  5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Eligibility: Inclusion Criteria:
  -  histologically confirmed with malignant tumor;
  -  Age: 18-80 years;
  -  an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  At least one measurable lesion according to the RECIST criteria;
  -  Adequate bone marrow, cardiac, liver, and renal function;
  -  Life expectancy ≥2 months;
  -  Not received other anti-tumor treatment
  -  Informed consent signed
  Exclusion Criteria:
  -  previous history of other malignancies;
  -  Uncontrolled central nervous system metastases;
  -  Serious or uncontrolled concurrent medical illness.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

Summary: The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
  -  Age 18-70
  -  No evidence of distant metastasis
  -  No previous therapy
  -  Normal hematologic function
  -  No abnormality of renal or liver function
  -  Written informed consent
  Exclusion Criteria:
  -  With allergic constitution or possible allergic reflection to drugs to be used in this study
  -  Any concurrent uncontrolled medical or psychiatric disorder
  -  History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
  -  Being pregnant or nursing

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility: Inclusion Criteria:
  -  KRAS and NRAS wild type metastatic colorectal cancer
  -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  -  Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  -  Prior radiation to the pelvis or abdomen
  -  Patients with history of interstitial lung disease.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Laser Therapy for the Management of Radiation Dermatitis

Summary: Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.
  LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.


Eligibility: Inclusion Criteria:
  -  Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma
  -  Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
  -  Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
  -  Provide signed informed consent
  Exclusion Criteria:
  -  Previous irradiation to the same breast
  -  Metastatic disease
  -  Mastectomy surgery
  -  Concurrent chemo-radiotherapy
  -  Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

Summary: The purpose of this project is to establish a repository of information and samples from breast cancer patients or those at high risk of developing breast cancer, who are initiating hormone therapy as part of standard clinical care or prevention. This repository will include patient reported outcomes and other questionnaires, information on medication use, data about adherence to the hormone therapy and tumor characteristics, including prospectively collected samples.

Detailed description: This research is being done to learn more about the side effects of breast cancer hormone therapy and if a person's genetic information may help us to develop a way to predict the side effects a patient may have and how best to treat them. In addition, the investigators hope to look at how the side effects from hormone therapy influence a patient's willingness to continue hormonal treatment.
  Men and women being prescribed hormone therapies including Tamoxifen, Raloxifene (Evista), Anastrozole (Arimidex), Letrozole (Femara), or Exemestane (Aromasin), by their oncologist for either prevention of breast cancer or treatment of breast cancer may join.
  The decision of which hormone therapy to receive is the decision of the patient and physician, this study will collect samples and patient-reported outcomes during this routine, standard of care and will not direct any treatment decisions or interventions in any way.

Eligibility: Inclusion Criteria:
  -  Male or female
  -  18 years of age or older
  -  Physically and cognitively able to complete the questionnaires
  -  Meet one of the following categories: 1) Initiating hormonal therapy for breast cancer prevention. All patients planned to initiate hormonal therapy with either Tamoxifen, Raloxifene (Evista®), Anastrozole (Arimidex®), Letrozole (Femara®) or Exemestane (Aromasin®) are eligible; concomitant use of Zoladex or Lupron is permitted; 2) Patients with histologically proven ductal carcinoma in situ (DCIS/stage 0) or stage I-III invasive carcinoma of the breast that is estrogen (ER) and/or progesterone (PR) positive by immunohistochemical staining, who are considering one of the above listed SERMs or AIs. These patients must have completed any planned chemotherapy and local therapy (e.g., lumpectomy or mastectomy); however, enrollment/initiation of hormonal therapy on study may be done prior to completion of radiation and/or biologic therapy (e.g., trastuzumab) at the discretion of the treating team; or, 3) The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
  -  Patients transitioning from one hormonal agent listed above to another may be enrolled prior to initiation of the new medication.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Summary: This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age, with locally advanced breast cancer.
  Exclusion Criteria:
  -  previous therapy for any invasive malignancy.

Relevance to patient case: not relevant