araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with cholangiocarcinoma; genetic feature: BRAF (V600E)

Clinical trial: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Summary: This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.


Eligibility: Inclusion Criteria:
  1. BRAF V600 mutation in solid tumor.
  2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
  3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
  4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
  5. ECOG performance status of 0-1.
  6. Life expectancy ≥ 3 months.
  7. Ability to take the medicine orally.
  8. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hypersensitivity to study drug ingredients or their analogues.
  2. Prior therapy with MEK-inhibitor.
  3. Receiving any other anti-cancer therapy at the same time .
  4. Active central nervous system (CNS) lesion.
  5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
  6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
  7. Uncontrolled concomitant diseases or infectious diseases.
  8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
  9. History of HIV,HCV,HBV infection.
  10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
  11. Serum HCG test is positive.
  12. Other conditions that increase the risk of study and influence the result.

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with cholangiocarcinoma; genetic feature: BRAF (V600E)

Clinical trial: An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Summary: This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.


Eligibility: Key Inclusion Criteria:
  -  Histologically confirmed diagnosis of melanoma.
  -  Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local assay at any time prior to Screening or by a central laboratory during Screening.
  -  Metastatic disease to the brain with at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension.
  -  Patients may have received no more than 1 prior line of checkpoint inhibitor therapy.
  -  An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score ≥ 80
  -  Adequate bone marrow, organ function and laboratory parameters
  Key Exclusion Criteria:
  -  Patients with symptomatic brain metastasis.
  -  Patients requiring corticosteroids for brain metastasis.
  -  Uveal or mucosal melanoma.
  -  History of or current leptomeningeal metastases.
  -  Prior local treatment for brain metastasis, including whole brain radiation therapy, stereotactic radiosurgery or craniotomy.
  -  Either of the following:
  1. Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment;
  2. Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
  -  Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 12 months prior to enrollment. Patients treated in the adjuvant setting with B-RAF proto-oncogene, serine/threonine kinase (BRAF) or mitogen-activated protein kinase (MEK) inhibitors ≥ 12 months prior to enrollment are eligible. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
  -  Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment.

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate

Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer.
  PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.

Detailed description: OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality of life of these patients.
  OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0 versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and family history (prostate cancer in brother, father, or uncle versus no prostate cancer in these relatives). Patients are randomized to one of two treatment arms.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed high grade prostatic intraepithelial neoplasia Confirmed by second prostate biopsy within 180 days of first biopsy No prior or concurrent prostatic carcinoma No prior hormonal replacement or antiandrogen therapy
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 5 years Hematopoietic: Not specified Hepatic: SGOT and alkaline phosphatase no greater than 2 times upper limit of normal No hepatitis B or C or liver cirrhosis Renal: Not specified Other: Fertile patients must use effective contraception No other prior malignancy in past 5 years except carcinoma in situ or nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
  PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
  -  Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
  -  Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.

Eligibility: DISEASE CHARACTERISTICS:
  -  Healthy male volunteers
  -  Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry
  -  Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
  -  Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
  -  No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia
  PATIENT CHARACTERISTICS:
  Age:
  -  See Disease Characteristics
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Cardiovascular:
  -  Systolic blood pressure < 160 mm Hg
  -  Diastolic blood pressure < 90 mm Hg
  -  No history of hemorrhagic stroke
  Other:
  -  No malignancies within the past 5 years except basal cell or squamous cell skin cancer
  -  No uncontrolled medical illness
  -  No retinitis pigmentosa
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
  -  No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
  -  Concurrent multivitamins allowed (supplied on study)
  -  No concurrent anticoagulation therapy (e.g., warfarin)
  -  Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed
  -  Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
  -  Concurrent anti-hypertension medication allowed
  -  No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Assessing Quality of Life of Patients With Prostate Cancer

Summary: RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.
  PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

Detailed description: OBJECTIVES:
  -  Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer.
  OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease).
  Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy.
  PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed prostate cancer
  -  Stratum I:
  -  Clinically localized primary prostate cancer
  -  T1-T3, G1-G3, N0, M0
  -  Plan to undergo a radical prostatectomy OR
  -  Local or locally advanced primary prostate cancer
  -  T1-T4, G1-G3, N0, M0
  -  Plan to undergo radiotherapy with curative intent
  -  Stratum II:
  -  Metastatic prostate cancer
  -  T1-T4, G1-G3, N1, M0-M1 OR
  -  T1-T4, G1-G3, N0-1, M1
  -  Plan to receive hormonal treatment
  -  No anti-androgen monotherapy
  -  No cerebral metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Mentally fit to complete a questionnaire
  -  Literate in the language of the questionnaires
  -  No psychological, familial, sociological, or geographical condition that would preclude compliance
  -  No other concurrent malignancy except basal cell skin cancer
  -  No concurrent participation in other quality of life investigations that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  See Disease Characteristics
  -  No prior neoadjuvant hormonal treatment
  -  Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I
  Radiotherapy:
  -  See Disease Characteristics
  -  No interstitial radiotherapy
  -  More than 2 years since prior radiotherapy (stratum II)
  Surgery:
  -  See Disease Characteristics
  -  More than 2 years since prior prostatectomy (stratum II)
  Other:
  -  No prior treatment for prostate carcinoma

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Effectiveness of Advisor-Teller Money Manager

Summary: VA investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. The proposed research addresses an important VA priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse.

Detailed description: Background:
  VA investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. The proposed research addresses an important VA priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse.
  Objectives:
  The objective was to determine the effectiveness of a money management-based therapy called ATM for veterans who abuse cocaine or alcohol compared to a financial advice control condition.
  Methods:
  Veterans were randomly assigned to 36-weeks of ATM or to the control condition, financial advice. ATM (Adviser-Teller Money Manager) involves meeting with a money manager at least weekly. The money manager performs three functions�limiting patients� access to funds by storing checkbooks and ATM cards, training patients to budget their funds, and linking spending to treatment goals. The control condition involved listing income and expenses in a workbook. Veterans were enrolled from each of two sites if they had spent at least $100 in the preceding 90 days on alcohol or cocaine, and had at least $300 per month income. Measures of treatment fidelity and participation included number of visits attended, whether funds were stored, monthly income and expenses and Likert-scaled ratings from 1-4 of money management-related outcomes. Outcome measures collected included urine toxicology tests and breathalyzers, self-reported substance use as assessed by the ASI follow-up, and secondary measures including quality of life and psychiatric symptomatology.
  Status:
  Data analysis is ongoing. Attempts are being made to (a) disseminate ATM and assess its effect among homeless women veterans (b) determine the reliability and validity of money management-based assessments used to determine which veterans are capable of managing their funds (c) optimize funds management by disabled veterans.

Eligibility: Inclusion Criteria:
  Age _>18. Meets DSM-II criteria for cocaine abuse or alcohol abuse. Self-reported use of at least $100 worth of alcohol or cocaine during 30 days within last 90 days. Income of at least $300 per month.
  Exclusion Criteria:
  Currently receives money management, physiological dependence on alcohol or opiates, has a conservator or other payee

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Tetrathiomolybdate in Hormone Refractory Prostate Cancer

Summary: Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.

Detailed description: Tetrathiomolybdate or TM, a drug developed for Wilson's Disease, removes copper from the bloodstream. Copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in the body but becomes uncontrolled in cancerous cells. Tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. Realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with Tetrathiomolybdate for different types of cancers. This clinical trial will evaluate the effectiveness of Tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment.

Eligibility: Inclusion:
  -  Patients must have histologic diagnosis of adenocarcinoma of the prostate with progression following hormonal therapy and antiandrogen withdrawal.
  -  Patients must have minimal disease (defined as bone metastasis or visceral disease with no impairment of organ function or pain severe enough to require narcotics for control).
  -  Adequate bone marrow and renal function
  -  ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (a measure of general well being where 1 represents asymptomatic and 5 represents death)
  -  Life expectancy of at least 16 weeks
  -  Must have completed radiation more than 4 weeks prior to registration and must have a rising PSA (Prostate Specific Antigen) and lesion outside of the radiation field
  Exclusion:
  -  Patients with an elevated PSA as the only evidence of disease
  -  Clinical evidence of spinal cord compression
  -  History of prior malignancy within the past 5 years (with the exception of in situ carcinoma of any site or nonmelanoma skin cancer)

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

Summary: To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

Detailed description: -  Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
  -  Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
  -  Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
  -  Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
  -  In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
  -  Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
  -  Documentation of key family member cancer diagnoses is required
  Exclusion Criteria:
  -  Males, will be offered BRCA 1/2 testing through other protocols
  -  Individuals unable to speak or write English
  -  Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
  -  Life expectancy of less than 12 months.

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: ATM Variants in Radiotherapy Patients

Summary: The purpose of this study is to compare the baseline incidence of variant alleles in the ATM and/or other DNA repair genes present in the Native American population versus the non-Native American population. It is thought that a higher baseline incidence of the variant alleles in the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in the Native American population.


Eligibility: Inclusion Criteria:
  -  Indication for radiotherapy.
  -  Ability or desire to donate a blood sample and be followed closely for radiation toxicities

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

Summary: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Detailed description: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Eligibility: Inclusion Criteria:
  -  prostate cancer
  Exclusion Criteria:
  -  contraindication to MRI

Relevance to patient case: not relevant