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

Clinical trial: Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Summary: RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to test in the laboratory may help the study of cancer.
  PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial cancer.

Detailed description: OBJECTIVES:
  -  To generate a translational ovarian cancer model using tumor tissue and cells from patients with stage III-IV ovarian/primary peritoneal/fallopian tube epithelial cancer for drug response and development.
  OUTLINE: Tissue and fluid samples are collected at the time of surgery or paracentesis and used in laboratory experiments and in animal models. Health data is collected from patient medical records before, during, and after surgery.
  After surgery, patients are followed up for 5 years.

Eligibility: INCLUSION:
  • Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial ovarian malignancies.
  EXCLUSION:
  -  Patients with less than Stage III epithelial ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma
  -  Patients who have received prior chemotherapy
  -  Patients who have nonepithelial ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma
  -  Patients who have malignancy other than ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma

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

Clinical trial: Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

Summary: This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.
  II. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.
  III. To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.
  V. To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).
  OUTLINE: This is a multicenter study.
  Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.

Eligibility: Inclusion Criteria:
  -  Enrolled on GOG-0199
  -  Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
  -  Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
  -  No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)

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

Clinical trial: Analysis of Tumors From Patients With Inherited Cancers Having Had Two Surgeries (Primary + Recurrent, or 2 Separate Types of Cancer)

Summary: This study will analyze tumor tissue from patients with known genetic mutations (BRCA1, BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either primary/recurrent, or two different anatomical sites.

Detailed description: This study will recruit individuals with known BRCA1 and BRCA2 mutations or mutations in similar cancer causing genes such as CHK2 or PALB2 who have had a cancer removed by surgery or biopsied two or more times with available pathological blocks. We wish to enroll individuals who have had more than one surgery or biopsy for cancer allowing us to obtain tumor blocks from more than one time point. Such patients would include those with one cancer which has recurred or more than one separate cancer. We will conduct a brief interview with the subject to obtain personal information about medical and treatment history. In addition, we will collect clinical information from their treating physician(s) to correlate molecular findings with clinical responses to treatment and survival and recurrence data. We will collect background clinical information and family history information and a copy of the genetic test results documenting their cancer causing mutation. We will recruit only patients with known BRCA1 or BRCA2 mutations or known mutations in other cancer causing genes such as CHK2 or PALB2 and will not perform genetic testing on non-tumor tissue for any new information on genetic susceptibility in patient samples. Enrolled subjects will donate a blood sample that will be obtained locally and shipped to the research laboratory, and this cost will be entirely covered by the research group.

Eligibility: Inclusion Criteria:
  -  Male or female
  -  Age 18 or older
  -  documented mutation in BRCA1, BRCA2 or other known cancer causing gene
  -  one or more cancer with available stored tissue blocks or slides
  -  willing to donate 16cc of blood
  -  able to understand English and provide informed consent
  Exclusion Criteria:
  -  unable or unwilling to provide informed consent
  -  patient does not have tissue blocks available
  -  minor, under age 18

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

Clinical trial: Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

Summary: The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.

Detailed description: Epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because 80% of tumors have metastasized beyond the ovary at the time of diagnosis. Screening efforts aimed at improved identification of early stage disease have been largely unsuccessful, because of ovarian cancer's propensity for early spread. Our hypothesis is that this obstacle can be circumvented by identifying biomarkers for the precancerous stage of this disease. Since this pre-cancerous stage is currently undetectable, we instead propose to look for biomarkers in women at very high risk for developing ovarian cancer due to genetic mutations. We hypothesize that identification of markers for genetic predisposition to ovarian cancer will also be informative for detection of biological changes that over time lead to sporadic cancers. Given their increasingly recognized role in states of normal and abnormal growth and differentiation, we hypothesize that short non-coding RNAs (sncRNAs) hold significant promise as biomarkers of ovarian cancer predisposition. We will test these hypotheses in two aims. First, we will identify biomarkers for hereditary ovarian cancer risk by comparing serum-derived sncRNAs in women with and without hereditary risk for ovarian cancer. In the second aim we will define serum-derived sncRNAs correlates of ovarian cancer disease status. We will compare sera from ovarian cancer patients at times of highest and lowest disease burden to those of control, cancer-free subjects. Each aim will provide independent, novel, and important information for future investigations. The sncRNAs found to be differentially expressed in both aims will be prioritized for future validation in women under clinical surveillance for hereditary risk of ovarian cancer.

Eligibility: Inclusion Criteria:
  -  Undergoing medical care at UVA
  -  Up to date breast cancer screening
  -  Subjects must fall into one of the following groups:
  -  Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries.
  -  Women at average risk for ovarian cancer
  -  Women with known/suspected or recurrent ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center
  Exclusion Criteria:
  -  Subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma
  -  Pregnancy (self reported)

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

Clinical trial: Retrospective Study of Ovarian Cancer Patients With Brain Metastasis

Summary: Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. In the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.

Detailed description: The ovarian cancer patient treated at the Department of Obstetrics and Gynecology of the National Taiwan University Hospital were retrospectively collected. The cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. The medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. Patients with other synchronous primary brain tumor were excluded. The initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. The intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (CT) and magnetic resonance imaging (MRI) scans. Therapeutic strategies for the metastatic lesions in the brain were also reviewed. All statistical analyses were performed using the SPSS 13.0 statistical software for Windows. P<0.05 was defined as statistical significance. Survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by Kaplan-Meier curves.

Eligibility: Inclusion Criteria:
  -  Patients with ovarian cancer and brain metastasis
  -  Patients ovarian cancer from National Taiwan University Hospital
  Exclusion Criteria:
  -  none

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

Clinical trial: Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Summary: This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
  -  Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
  -  18 years of age or older.
  -  Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  -  Have adequate organ function
  -  Able to take oral medications.
  -  Willing and able to provide informed consent.
  -  Sexually active patients must be willing to use an acceptable method of contraception.
  -  Females of childbearing potential must have a negative serum pregnancy test at screening.
  -  Willing and able to comply with all study procedures.
  Part 2 Dose Expansion Tumor Types:
  -  Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
  -  Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
  -  Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
  -  Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.
  Exclusion Criteria:
  -  Part 2 Expansion: Prior treatment with a PARP inhibitor.
  -  Has history of central nervous system (CNS) metastasis.
  * Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms.
  -  Has had major surgery within 28 days before Cycle 1, Day 1.
  -  Has active peptic ulcer disease.
  -  Active gastrointestinal tract disease with malabsorption syndrome.
  -  Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.

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

Clinical trial: Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer

Summary: The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

Detailed description: The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.

Eligibility: Inclusion Criteria:
  -  Must meet one of the following:
  -  The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
  -  The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
  -  The subject has a male relative with breast cancer diagnosed at any age.
  -  Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
  Exclusion Criteria:
  -  Prior ovarian cancer or peritoneal carcinomatosis
  -  A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
  -  The subject has no ovaries.
  -  Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
  -  Currently pregnant
  -  Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
  -  Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
  -  Intraperitoneal surgery within the last 3 months.

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

Clinical trial: Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer

Summary: The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes


Eligibility: Inclusion Criteria:
  For patients
  -  Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
  -  Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
  -  Age ≥ 18 years
  -  Agreeing to participate in the study (a collection of signed informed consent)
  For control population
  -  Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
  -  Agreeing to participate in the study (a collection of signed informed consent)
  Exclusion Criteria:
  For patients:
  -  Patients with a known deleterious mutation in BRCA1 and BRCA2
  -  Patients do not meet criteria suggestive of a hereditary predisposition
  -  Persons deprived of liberty or under guardianship (including guardianship)
  For control population:
  -  Males
  -  Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
  -  Persons deprived of liberty or under guardianship (including guardianship)

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

Clinical trial: Development for the Peritoneal Carcinomatosis Index (PCI) in Ovarian Cancer

Summary: -  Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
  -  Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics

Detailed description: Patients with primary ovarian cancer
  -  Informed consent
  -  Digital photography & Checking PCI (tumor size, number, and Characteristics)
  -  Postoperative surveillance(tumor marker, image and physical examination)
  1. Developing the best fitting PCI model to reflect recurrence-free survival and overall survival
  -  Selection of items
  -  Weighting by items and tumor characteristics
  2. Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer

Eligibility: Inclusion Criteria:
  1. Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
  2. Available preoperative image study (CT and/or MRI and/or PET)
  3. Patients who gave a written informed consent
  4. Patients must be surgical candidate considering medical and psychological condition
  Exclusion Criteria:
  -  Patients who refuse to participate or want to withdraw at anytime.

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

Clinical trial: Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Summary: The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.


Eligibility: Inclusion Criteria:
  -  Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.
  Exclusion Criteria:
  -  Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
  -  Personal history of gynecologic cancer
  -  Pregnancy
  -  Non-English speaking
  -  Unable to provide informed consent

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

Clinical trial: Radical Fimbriectomy for Young BRCA Mutation Carriers

Summary: Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

Detailed description: Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.
  Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.
  The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion

Eligibility: Inclusion Criteria:
  -  Woman aged over 35 years
  -  When project of childbearing is fulfilled
  -  With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
  -  Unprepared to undergo bilateral annexectomy
  -  With or without breast cancer
  -  Patient affiliated to health insurance
  -  Dated and signed informed consent
  Exclusion Criteria:
  -  Menopausal woman defined as :
  Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH> 20 UI/l History of hysterectomy and FSH> 20 UI/l
  -  Pregnant or breastfeeding woman

Relevance to patient case: definitely relevant