araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Summary: The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.


Eligibility: Inclusion Criteria:
  -  Amenorrhoea for >= 12 months.
  -  Serum estradiol and FSH level within the postmenopausal range
  -  Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium
  Exclusion Criteria:
  -  Previous systemic unopposed estrogen replacement therapy over 6 months or more.
  -  Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
  -  History or presence of an estrogen dependent neoplasia (including breast- cancer).
  -  History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Disseminated Endometrial Cancer Cells During Sonohysterography

Summary: The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG


Eligibility: Inclusion Criteria:
  -  Stage I endometrial Cancer Disease
  -  State IIA endometrial Cancer Disease
  Exclusion Criteria:
  -  Prior tubal ligation
  -  Prior bilateral salpingectomy

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

Summary: RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.
  PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission.
  Secondary
  -  Determine the feasibility and acceptability of lifestyle interventions in these patients.
  OUTLINE: This is a randomized, controlled study. Patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
  -  Arm II: Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
  After completion of study treatment, patients are followed at 1 year.
  PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed endometrial cancer meeting the following criteria:
  -  Stage I or II disease
  -  Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
  -  Disease in remission
  -  Body Mass Index (BMI) ≥ 25
  PATIENT CHARACTERISTICS:
  Performance status
  -  ECOG 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  PRIOR CONCURRENT THERAPY: Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Trial of Adjuvant Chemotherapy for Gastric Cancer

Summary: This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Detailed description: Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.
  This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility: Inclusion Criteria:
  -  Pathologically proven gastric adenocarcinoma
  -  Curative resection was done
  -  stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
  -  age: 18-69 years old
  -  Performance status: ECOG 0-2
  -  Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
  -  Adequate renal function (serum creatinine≤ 1.5)
  -  Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)
  -  Written informed consent was signed by the patient
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy
  -  Active ongoing infection which antibiotic treatment is needed
  -  Pregnant or lactating women
  -  Psychosis or convulsion disorder
  -  Ascites in preoperative abdomen CT
  -  Systemic disease which interfere the administration of chemotherapy
  -  Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer

Summary: RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.
  PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.

Detailed description: OBJECTIVES:
  -  Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
  -  Compare 5-year rate of distant metastases in these patients.
  -  Determine overall survival rate in these patients.
  -  Determine prognostic factors for relapse and morbidity.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
  -  Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.
  PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility: INCLUSION CRITERIA:
  -  Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:
  -  Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
  -  Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion)
  -  Stage IIA, any age
  -  No grade 3 endometrial carcinoma with deep myometrial invasion
  -  Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
  -  WHO performance status 0-2
  EXCLUSION CRITERIA:
  -  Serous or clear cell histology or uterine sarcoma
  -  staging lymphadenectomy
  -  interval between surgery and radiotherapy > 8 weeks
  -  history of previous malignant disease (except basal cell carcinoma of skin)
  -  previous radiotherapy, hormonal therapy or chemotherapy
  -  diagnosis of Chrohn's disease or ulcerative colitis

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

Summary: The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Detailed description: Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed early-stage endometrial cancer
  Exclusion Criteria:
  -  Recurrent or persistent endometrial cancer
  -  Evidence of distant metastases

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Combined Colon and Endometrial Cancer Screening in Women With HNPCC

Summary: Primary Objectives:
  To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer.
  To measure patient satisfaction for the combined procedure.

Detailed description: Women with certain medical conditions have an increased risk for colon and endometrial cancer. Currently, women go through separate screening procedures. Endometrial biopsies are performed at a separate visit to the gynecologist, and patients are not sedated for the procedure. This study will involve performing an endometrial biopsy while you are sedated for your colonoscopy.
  Women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study.
  As part of the study, you will be asked about your past experience with endometrial biopsy and colonoscopy. You will be asked about your perception of pain, your expectations, and the benefits and barriers to the combined screening.
  You will then be sedated. The colonoscopy will be performed first by a gastroenterologist. This will be followed by the endometrial biopsy, which will be performed by a gynecologic oncologist.
  A telephone interview will be performed two weeks after this procedure. The interview will last about 15 minutes. You will be asked about your perception of pain and the benefits and barriers to the combined screening.
  This is an investigational study. A total of 50 women will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  1) Women with medical indications for colonoscopy and endometrial biopsy.
  Exclusion Criteria:
  1) Must be 18 years of age and older.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Summary: Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

Detailed description: The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.

Eligibility: Inclusion Criteria:
  -  Advanced Stage Endometrial Cancer (Stage 3 or 4)
  -  Any Histology including clear cell, and serous papillary carcinomas
  -  surgery must have had hysterectomy and bilateral salpingo-oophorectomy
  -  chemotherapy initiated 12 weeks after surgery
  -  sign informed consent
  -  Adequate End-organ function
  -  GOG (Gynecologic Oncology Group)Performance Status 0,1,2
  -  Patients must be 18 years or older
  -  Patients may have received radiation for the treatment of endometrial cancer.
  -  Patients may have measurable or non-measurable disease.
  Exclusion Criteria:
  -  Patient with concomitant malignancy other than non-melanoma skin cancer
  -  Patients with prior malignancy who have been disease free for 5 years.
  -  Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
  -  Patients whose circumstances will not permit study completion or adequate follow up
  -  Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Risk Factors for Endometrial Cancer in Black Women

Summary: RATIONALE: Learning about the risk factors for endometrial cancer in black women may help the study of endometrial cancer in the future.
  PURPOSE: This clinical trial is studying risk factors for endometrial cancer in black women.

Detailed description: OBJECTIVES:
  -  Establish and evaluate procedures for conducting a hospital-based case-control study of risk factors for endometrial cancer in black women.
  OUTLINE: This is a multicenter study.
  Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.
  PROJECTED ACCRUAL:
  -  A total of 30 cases and 30 controls will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Cases
  -  Diagnosed with endometrial cancer within the past year
  -  Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
  -  Healthy controls
  -  Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
  -  No history of endometrial or other cancer (except non-melanoma skin cancer)
  -  No prior hysterectomy
  PATIENT CHARACTERISTICS:
  -  Speak English
  -  No medical condition that would make it difficult to complete the interview
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

Summary: The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.
  The secondary objectives of this trial are to:
  -  compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
  -  evaluate the safety and tolerability of bevacizumab
  An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  operable primary invasive breast cancer;
  -  completed definitive loco-regional surgery;
  -  primary tumor centrally confirmed as triple negative.
  Exclusion Criteria:
  -  locally advanced breast cancers;
  -  previous breast cancer history;
  -  clinically significant cardiovascular disease.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Estrogen, Diet, Genetics and Endometrial Cancer

Summary: The purpose of this study is to see how people's diets, other aspects of their lifestyles, and their individual genetic makeup affect their chances of getting endometrial cancer (cancer of the uterus).
  This survey will enroll several hundred women who have or have had endometrial cancer and several hundred who do not. We will compare these two groups of women to see what factors may lead to endometrial cancer.

Detailed description: We will conduct a population-based case-control study in six counties of New Jersey. Cases will be women with newly-diagnosed endometrial or ovarian cancer. Controls will be matched by 5-year age groups and selected by random digit dialing (for those under 65), from Centers for Medicare and Medicaid Services (CMS) files (for those 65 and over), or from neighborhood sampling. Controls will not have had a hysterectomy.
  There will be 400 cases with endometrioid tumors, 60 with serous tumors or clear cell tumors, 300 with ovarian cancer, and 400 controls. In addition, there will be a small group of black women included from MSKCC.
  We will interview participants about known and potential risk factors for endometrial and ovarian cancer and obtain information on diet. We will obtain DNA for genetic analysis from buccal specimens collected using a mouthwash rinse method. We will use logistic regression to determine odds ratios for disease with various exposures. For endometrial cancer, we will examine the association of risk with genotypes in strata defined by body mass index and dietary fat consumption.

Eligibility: Inclusion Criteria:
  -  Diagnosed with epithelial endometrial or ovarian cancer within the year before being contacted (cases)
  -  Aged 21 and over
  -  Residents of Essex, Union, Morris, Middlesex, Bergen, or Hudson counties, NJ
  -  Black women with and without endometrial cancer who are seeing gynecologists at MSKCC
  Exclusion Criteria:
  -  Unable to sign informed consent
  -  Consent withheld by physician (cases)
  -  Hysterectomy (controls)
  -  Do not speak English or Spanish

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma

Summary: The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.
  Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.
  The treatment also includes removing lymph nodes from the pelvis.

Detailed description: Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.
  ↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.
  ↓ Intraoperative lymphatic mapping with blue dye and gamma probe.
  ↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Eligibility: Inclusion Criteria:
  -  Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
  -  Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
  -  Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
  -  Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
  -  Patients with clinical stage I endometrial cancer
  -  Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
  -  Patients who have signed an approved informed consent.
  Exclusion Criteria:
  -  Patients with history of prior pelvic or para-aortic lymphadenectomy.
  -  Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
  -  Patients with recurrent endometrial or cervical cancer.
  -  Patients with prior pelvic radiation.
  -  Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
  -  Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
  -  Patients with grossly infected primary tumors.
  -  Patients with known allergy to triphenyl-ethane compounds.
  -  Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
  -  Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
  -  Severe Renal Disease.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Molecular Markers in Treatment in Endometrial Cancer

Summary: The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

Detailed description: This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.

Eligibility: Inclusion Criteria:
  -  Women with endometrial carcinoma
  -  Available endometrial biopsy
  -  Informed consent
  Exclusion Criteria:
  -  No informed consent

Relevance to patient case: not relevant