araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Summary: BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter feasibility trial is that a structured life-style intervention program with exercise training and mediterranean diet is feasible and improves the nutritional and fitness status as well as the weight, the quality of life and stress reacting capacity.


Eligibility: Inclusion Criteria:
  -  women with proven pathogenic BRCA1/2 mutation
  Exclusion Criteria:
  -  metastatic tumor disease
  -  life expectancy <3 years
  -  clinically limiting cardiovascular or respiratory disease
  -  significant orthopedic disability which prevents from participating in the exercise training
  -  severe concomitant disease which prevents from participating in the group interventions
  -  Karnofsky index <60
  -  VO2max >150%
  -  Maximal exercise capacity < 50 W
  -  food allergies which prevent from mediterranean diet
  -  vegan diet
  -  body mass index <15 kg/m2
  -  pregnancy
  -  insufficient knowledge of German language
  -  insufficient compliance
  -  active participation in other interventional trials
  -  no informed consent

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Photoacoustic Imaging of the Ovary

Summary: The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Detailed description: Epithelial ovarian cancer causes the highest mortality of any of the gynecologic cancers although it is the second most common gynecologic malignancy. Ovarian cancer is not usually detected earlier than Stage III or IV because it is usually asymptomatic; yet survival is high with early stage disease. In addition, women with a pelvic mass noted on ultrasound that undergo oophorectomy have only a 1-3% risk of malignancy and thus 97-99% will be overtreated because of our inability to reliably differentiate benign from malignant masses with ultrasound. BRCA1 testing and family history will identify certain high-risk individuals who have a higher risk of malignancy and need a modality that will be more reliable in detecting early cancers to provide more accurate surveillance.We are developing a new transvaginal imaging device optimized for ovarian cancer detection, diagnosis and validated from ex vivo and in vivo clinical studies. This automated system may provide an early diagnostic tool for ovarian cancer in the future.

Eligibility: Inclusion Criteria:
  -  All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy.
  -  Patients cannot be pregnant or wish to become pregnant.
  -  Willingness to participate in the study.
  Exclusion Criteria:
  -  All Subjects who fail to meet the inclusion criteria are ineligible for the study.

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Summary: This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.


Eligibility: Inclusion Criteria:
  -  Undergo BRCA1/2 genetic counseling and testing at one of four study sites
  -  Receive positive or uninformative test results
  -  English speaking
  Exclusion Criteria:
  -  Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
  -  Previous bilateral mastectomy

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Cancer Prevention in Women With a BRCA Mutation

Summary: This study aims to develop a follow-up telephone-based genetic counselling (FTGC) intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in the past. Typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. If a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. However, in Canada, there is currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing guidance and support about latest risk reduction strategies. Standard care relies on women making contact for any follow-up questions or concerns they may have. As a result, these women might not have the most current information regarding genetic risk assessment and prevention options. Therefore, individuals are being asked to participate in this study to aid research about the efficacy of FTGC in women with a BRCA mutation.


Eligibility: Inclusion Criteria:
  -  Confirmed BRCA mutation
  -  Age 35 to 70 years
  -  No previous bilateral salpingo-oophorectomy
  -  No previous or current ovarian cancer
  -  At least 12 months since genetic testing or most recent contact by Narod follow-up study
  -  Can speak and understand English
  Exclusion Criteria:
  -  Currently receiving treatment for another cancer diagnosis
  -  Pregnant
  -  Given birth in the last 6 months
  -  Booked surgical date for BSO

Relevance to patient case: definitely relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment

Summary: The investigators will recruit and enroll individuals that may have the KRAS-variant or other microRNA binding site mutations to join registry studies. The investigators will allow individuals to obtain their results through a physician at the completion of the studies. The investigators current focus is cancer and autoimmunity.

Detailed description: The investigators have identified germ-line microRNA binding site mutations that predict an increased risk of cancer, endometriosis and associated infertility, and unique tumor biology and response to treatment. The goal of this protocol is to further determine the mechanisms of these mutations, such as the KRAS-variant, and their associations with human health, such as cancer. The investigators will collect saliva samples from individual patients who are eligible and choose to enroll in these studies, to test for the KRAS-variant and/or other mutations under study. With specific permission, the investigators will keep excess DNA to further investigate and discover additional similar mutations. The investigators purpose is to have participants answer questionnaires about lifestyle factors in an ongoing manner, to understand the impact of different factors on cancer risk for patients with these mutations.

Eligibility: Inclusion Criteria:
  -  Personal or family history of cancer
  -  Personal history of endometriosis, or autoimmunity
  Exclusion Criteria:
  -  Younger than 18
  -  Non-english speaking and unable to understand and sign the consent

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

Summary: PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Detailed description: This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Eligibility: Inclusion criteria include:
  Triple Negative Breast Cancer
  -  ER/PR <10% and HER negative per current ASCO/CAP guidelines
  -  Stages I-IV
  -  Any age at diagnosis
  -  Patient must be within 5 years of diagnosis
  -  Eligible regardless of genetic testing status
  -  Genetic testing recommended for patients meeting NCCN and Medicare guidelines
  AND/OR
  Germline mutation Carriers
  -  Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
  -  Healthy patients harboring mutations also eligible
  -  There is no time limit from the time of diagnosis of cancer and enrollment.
  -  Eligible regardless of personal history of cancer
  Exclusion Criteria include:
  Triple Negative Breast Cancer -Patient is not within five years of diagnosis
  Germline mutation Carriers:
  -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: BRCA1 and BRCA2 Mutation in Romanian Population: a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival

Summary: Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by specific criteria for high-risk status including age at disease onset.
  Secondary objective Considering the fact that BRCA testing is not a routine procedure in Romania and mutation prevalence varies in different populations, we intend to look for the founder mutation in our population, running full BRCA genes sequencing to a representative population sample. This would allow a more targeted approach to real-life practice and would ensure personalized solutions for every patient in need.


Eligibility: Inclusion Criteria:
  Categories of patients to be recruited for complete sequencing of all BRCA1 and BRCA2 exons are subjects who have been diagnosed with breast or ovarion cancer and who are:
  1)40 years of age or younger 2)Triple negative breast cancer diagnosed before 50 years of age 3)Male with breast cancer 4)Bilateral breast cancer, first tumor diagnosed before 50 years of age 5)2) + 50 years of age or younger with at least one (first degree) relative diagnosed with breast cancer at 50 years of age or younger or a first degree relative with ovarian cancer 6)of any age with 2 or more relatives with breast cancer 7)of any age with 2 or more relatives with ovarian cancer 8)of any age with a personal history of ovarian cancer, tuba or peritoneal carcinoma 9)Two patients in same branch of the family, Prostate ca < 60 yr and 1st degree relative with BC < 50 yr 10)Two or more 1st and 2nd degree relatives of a patient with breast cancer, at least one of them <50 yr 11)of any age with a family history of male breast cancer or are at increased risk of having a BRCA mutation based on BRCAPRO or Tyrer-Cuzick models
  Exclusion Criteria:
  -

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers

Summary: The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Detailed description: Eligible women will choose for the innovative or standard risk-reducing option themselves.

Eligibility: Inclusion Criteria:
  -  Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
  -  Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
  -  Childbearing completed
  -  Presence of at least one fallopian tube
  -  Participants may have a personal history of non-ovarian malignancy
  Exclusion Criteria:
  -  Postmenopausal status (natural menopause or due to (cancer) treatment)
  -  Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
  -  Legally incapable
  -  Prior bilateral salpingectomy
  -  A personal history of ovarian, fallopian tube or peritoneal cancer
  -  Evidence of malignant disease at enrollment
  -  Treatment for malignant disease at enrollment
  -  Inability to read or speak Dutch
  BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.

Summary: BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22% germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype, including those women who have no family history of breast or ovarian cancer. With the rapid advancement of therapeutics targeted this population, this protocol seeks to provide genetic BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may help in selection of future treatment options and genetic testing for BRCA1/2 may be used to potentially prevent a proportion of cancer for the family members.
  This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population.

Detailed description: Primary Objectives
  · To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
  Secondary Objectives
  -  To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA1/2
  -  To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA1/2-positive
  -  To correlate impact of BRCA1/2 mutational status on clinical outcome
  -  To track utilization of genetic counseling services at Princess Margaret Cancer Centre

Eligibility: Inclusion Criteria:
  -  Patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort
  -  Patient must be ≥18 years old
  -  All patients must have sufficient archival tumor tissue for molecular analysis
  -  All patients must consent to have a genetic testing
  -  All patients must have signed and dated an informed consent form
  Exclusion Criteria:
  · Other histology subtype

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Summary: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs)


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years.
  -  Voluntary signed informed consent (IC)
  -  Pathologically proven diagnosis of any of the following malignancies:
  -  Small cell lung cancer (SCLC).
  -  Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
  -  Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
  -  Biliary tract carcinoma.
  -  Endometrial carcinoma.
  -  BRCA 1/2- associated metastatic breast carcinoma
  -  Carcinoma of unknown primary site.
  -  Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
  -  Ewing's family of tumors (EFTs)
  -  Prior treatment. Patients must have received:
  -  SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
  -  H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
  -  GCTs: no limit of prior therapy
  -  EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
  -  BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
  -  Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
  -  Adequate major organ function
  -  At least three weeks since the last chemotherapy
  -  Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry
  Exclusion Criteria:
  -  Prior treatment with PM01183 or trabectedin
  -  Prior or concurrent malignant disease unless in complete remission for more than five years
  -  Known central nervous system (CNS) involvement
  -  Relevant diseases or clinical situations which may increase the patient's risk
  -  Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: The Link Between BRCA Mutation and Endothelial Function

Summary: This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.


Eligibility: Inclusion Criteria:
  -  Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
  -  Able and willing to sign an informed consent
  Exclusion Criteria:
  -  History of, or current, malignancy
  -  History of:
  -  Myocardial infarction
  -  Ischemic or Hemorrhagic cerebrovascular conditions
  -  Arterial embolic and thrombotic events
  -  Ischemic heart disease
  -  Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
  -  Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population

Summary: The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.


Eligibility: Inclusion Criteria:
  -  Signed written informed consent
  -  Women aged ≥ 18 years
  -  Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
  -  Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
  -  Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
  -  Patients are able to read and understand German, English, Turkish or Arabic
  Exclusion Criteria:
  -  Known hypersensitivity to olaparib or any of the excipients of the drug
  -  Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
  -  Pregnancy or breast feeding

Relevance to patient case: definitely relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Summary: The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Detailed description: BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Eligibility: Inclusion Criteria:
  -  proven pathogenic BRCA1/2 mutation
  -  age >=18
  -  written informed consent
  Exclusion Criteria:
  -  current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
  -  metastatic tumor disease
  -  life expectancy <3 years
  -  clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
  -  significant orthopedic disability which prevents from participating in the group interventions
  -  severe concomitant diseases which prevents from participating in the group interventions
  -  Karnofsky index <60
  -  maximum exercise capacity <50 W
  -  food allergies which prevent from mediterranean diet
  -  vegan diet
  -  body mass index <15 kg/m2
  -  pregnancy
  -  insufficient knowledge of German language
  -  insufficient compliance
  -  active participation in other interventional trials

Relevance to patient case: not relevant