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

Clinical trial: Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy

Summary: Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

Detailed description: In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

Eligibility: Inclusion Criteria:
  -  Patient with recurrent ovarian cancer
  -  Second-line chemotherapy
  -  > = 18 years of age
  -  ECOG < = 2
  Exclusion Criteria:
  -  ECOG > 2
  -  Patients with more than one chemotherapy in anamneses

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

Clinical trial: National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

Summary: The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.

Detailed description: Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study
  Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):
  Primary outcome measures:
  Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
  Secondary outcome measures:
  Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.
  Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.
  Study start : January 2007. Expected completion 2010.
  Women with BRCA gene mutations are more likely than others to develop the disease at a young age when breast density is higher than at older age.The tumours often are more rapidly developing with a short presymptomatic phase. These factors are known to reduce the effectiveness of screening with mammography and mammography seems to have a low sensitivity in women with BRCA gene mutations. Other studies have shown that more than 50% of the cancers appears as interval cancers between two mammography screening examinations and many have positive axillary nodes at the time of diagnosis.
  Around 610 women are tested BRCA gene positive in Denmark in year 2006. These women are offered a yearly screening with mammography combined with ultrasound and a clinical examination. The trial will test whether this screening offer should be combined with or replaced by MR mammography.

Eligibility: Inclusion Criteria:
  -  women tested positive of BRCA1 or BRCA2 gene mutations
  -  referred for screening
  -  aged 25 - 70 years
  Exclusion Criteria:
  -  general contraindications for MR
  -  pregnant or lactating
  -  men
  -  bilateral mastectomy
  -  ongoing treatment with chemotherapy
  -  metastatic breast cancer
  -  previous breast surgery less than 6 months before MR
  -  previous radiation therapy of the breast less than 1 year before
  -  incapable of managing her own affairs

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

Clinical trial: Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

Summary: RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.
  PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.

Detailed description: OBJECTIVES:
  -  Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
  -  Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
  -  Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
  -  Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
  -  Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.
  OUTLINE: This is a multicenter study.
  Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.
  -  Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.
  -  Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.
  Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation
  -  Prior diagnosis of breast cancer allowed
  -  Must not be undergoing active treatment
  -  Patients with prior bilateral mastectomy are eligible for study but not eligible for randomization
  PATIENT CHARACTERISTICS:
  -  Female only
  -  No psychiatric or cognitive disorder that would preclude giving informed consent
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Summary: Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Detailed description: Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Eligibility: Inclusion Criteria:
  -  Patients with histological confirmation of non-small-cell lung carcinoma.
  -  Complete surgical resection of the disease.
  -  Tumoral tissue available for molecular analysis.
  -  N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
  -  Men or women age 18 years or older.
  -  Patients with a performance status of 2 or less according to the ECOG classification.
  -  Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
  -  Complete recovery from surgery within 6 weeks.
  -  Patients who have given written informed consent before initiating any specific study screening procedure.
  Exclusion Criteria:
  -  Patients who have received previously chemotherapy or radiotherapy for the study disease.
  -  Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
  -  Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
  -  Women who are pregnant or in the period of lactation.
  -  Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
  -  Patients under treatment with investigational agents.

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

Clinical trial: Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer

Summary: The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Eligibility: Inclusion Criteria:
  -  Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  -  Failed at least one prior chemotherapy
  -  In investigators opinion, no curative standard therapy exists
  -  Measurable disease
  Exclusion Criteria:
  -  Brain metastases
  -  Less than 28 days since last treatment used to treat the disease
  -  Considered a poor medical risk due to a serious uncontrolled disorder

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

Clinical trial: A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Summary: To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients.


Eligibility: Inclusion Criteria:
  -  Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.
  Exclusion Criteria:
  -  Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

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

Clinical trial: NYU Ovarian Cancer Early Detection Program Blood and Genetics

Summary: Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.

Detailed description: The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.
  This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.

Eligibility: Inclusion Criteria:
  Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
  -  A personal history of breast cancer
  -  One or more first degree relatives (mother, sister, daughter) with ovarian cancer
  -  Multiple family members with either breast and/or ovarian cancer
  -  A personal history of a positive BRCA1 or BRCA2 genetic test result
  -  A close relative with a positive BRCA1 or BRCA2 genetic test result
  -  A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
  -  Synchronous or metachronous endometrial and colorectal cancer
  -  A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
  -  A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
  -  A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
  -  The use of fertility drugs for more than one year

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

Clinical trial: Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations

Summary: The purpose of this study is to learn more about women's decision to undergo prophylactic surgery. This is removal of healthy organs in order to reduce risk of cancer. This study will help us to understand what makes women decide whether or not to have this kind of surgery.

Detailed description: For women with a strong family history of breast/ovarian cancer, few options exist for primary prevention of these cancers other than prophylactic surgery, or surgical removal of noncancerous organs in order to prevent occurrence of the disease. The primary aim of the study is to describe the stages of intention to undergo prophylactic mastectomy and/or oophorectomy among women seeking genetic testing for inherited BRCA1 and BRCA2 mutations, and to identify factors that influence stages of intention regarding prophylactic surgery. To achieve these aims, 626 women undergoing genetic counseling and testing for inherited breast ovarian cancer risk will be assessed before their first genetic counseling session and three times (1 week, 6 months and 12 months) in the year following notification of their genetic test results.

Eligibility: Inclusion Criteria:
  -  Female gender
  -  age 25 and above
  -  a personal or family history of breast and/or ovarian cancer showing clinical features associated with increased risk of carrying a BRCA1/2 mutation (e.g., breast and ovarian cancer on the same side of the family, early age of onset, multiple primaries in the same individual) or having a first-degree relative with a known BRCA1 or BRCA2 mutation.
  Exclusion Criteria:
  -  Male gender
  -  age less than 25 years
  -  unable to provide meaningful informed consent due to physical, cognitive or psychiatric disability
  -  non-English speaking

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

Clinical trial: Anonymous Testing of Pathology Specimens for BRCA Mutations in Ashkenazi Jewish Individuals Who Have Cancer

Summary: The intent of the proposed study is to describe the prevalence of the most common recurring mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish individuals with a variety of cancer diagnoses. If a substantial proportion of these samples contain such mutations, future patients presenting with these diseases may wish to undergo genetic counseling and, if appropriate, formal genetic testing. The benefit from such a process would pertain mainly to the families of these individuals.

Detailed description: Germline mutations in the genes BRCA1 and BRCA2 have been demonstrated in the majority of hereditary breast and ovarian cancer families. The increased risk to develop both breast and ovarian cancer associated with inheriting a BRCA1 or BRCA2 mutation has been well established. It has also been suggested that is an overrepresentation of other cancers such as colon, prostate and pancreatic cancer present in BRCA1 or BRCA2 families. Population specific mutations in BRCA1 and BRCA2 have been identified. In the Ashkenazi Jewish population, 3 specific mutations have been seen in 2% of the population. This study will anonymously screen archived tissue samples of Ashkenazi Jewish individuals diagnosed with cancer between 1993 and 1996 at MSKCC for the three founder mutations seen in the Ashkenazi Jewish population. Results will be stratified by tumor type and compared with the population frequency to determine whether individuals inheriting mutations in BRCA1 or BRCA2 may have an increased risk to develop other cancers, in addition to breast and ovarian cancer. This information will be useful in helping to identify individuals who may benefit from genetic counseling and possibly genetic testing who to date are not typically referred. It will also be useful in developing high-risk cancer screening strategies and determining appropriate options for prophylactic surgery.

Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer made at MSKCC or collaborating institutions, AND
  -  Tissue block of tumor or normal margin or extracted DNA available for study and sufficient material present to allow study without exhausting block or DNA,
  -  Individual self-identified as Jewish on intake.

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

Clinical trial: Korean Hereditary Breast Cancer Study

Summary: 1. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer.
  2. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer.
  3. To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
  4. To evaluate the prevalence of ovarian cancer of population of above 3 groups.

Detailed description: 1. To find founder mutation in Korean
  2. To correlation prevalence with risk evaluation
  3. To find risk factors concerning life style

Eligibility: Inclusion Criteria:
  -  Over 19 years old
  -  Agree to this study
  -  Breast cancer patient with family history of breast/ovarian cancer (1 subgroup)
  -  Breast cancer patient; young age (<40), bilateral, male, combined ovarian (2 subgroup)
  -  Family members with 1, 2 subgroups (3 subgroup)
  Exclusion Criteria:
  -  Under 20 years old
  -  Unable to decide for oneself

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

Clinical trial: Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

Summary: The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.


Eligibility: Inclusion Criteria:
  -  Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  -  Progressive or recurrent disease after platinum-based chemotherapy
  -  Measurable disease by RECIST
  Exclusion Criteria:
  -  Previous anthracycline treatment
  -  Brain metastases
  -  Less than 28 days since last treatment used to treat the disease
  -  Considered a poor medical risk due to a serious uncontrolled disorder

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

Clinical trial: Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Summary: The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.
  Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.

Detailed description: Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.
  Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

Eligibility: Inclusion Criteria:
  -  Female, age 18 or older;
  -  Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV);
  -  At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);
  -  Confirmed BRCA1 or BRCA2 status;
  -  One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI));
  -  Karnofsky performance status ≥70%;
  -  Estimated life expectancy of at least 16 weeks.
  Exclusion Criteria:
  -  Normal clinical laboratory values;
  -  Any anti-cancer therapy within 21 days prior to study start;
  -  Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer;
  -  Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection;
  -  Active central nervous system or brain metastases;
  -  History of seizures or current treatment with anti-epileptic medication;
  -  Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.

Relevance to patient case: possibly relevant