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

Clinical trial: Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

Summary: An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.


Eligibility: Inclusion Criteria:
  Stage I-III Criteria-
  -  Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
  -  Absence of metastatic disease evident from:
  -  physical examination
  -  the most recent chest X-ray
  -  abdominal CT or ultrasound scan
  -  Life expectancy of at least 3 months
  -  WHO performance status of 0 to 1
  -  Written informed consent given
  Stage IV Criteria-
  -  Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
  -  Life expectancy of at least 3 months
  -  WHO performance status of 0 to 2
  -  Written informed consent given
  Exclusion Criteria:
  -  History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
  -  Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
  -  Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
  -  Females who were pregnant, planning to become pregnant or lactating
  -  Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
  -  Previous G17DT treatment
  -  Haematological indicators:
  -  Haemoglobin <10.0g/dl
  -  White blood cell count <4.0 x 109/l
  -  Platelets <100 x 109/l

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

Clinical trial: Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Summary: The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Detailed description: In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.
  Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.
  Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Eligibility: Inclusion Criteria:
  -  18 - 38 years.
  -  patent fallopian tunes.
  -  mild male factor.
  -  anovulation.
  -  unexplained infertility.
  Exclusion Criteria:
  -  indications for ICSI.
  -  evidence of pelvic inflammatory disease.

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

Clinical trial: Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

Summary: This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.
  SECONDARY OBJECTIVES:
  I. To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.
  TERTIARY OBJECTIVES:
  I. To determine the effects of a 12-week behavior/exercise intervention for ethnically diverse endometrial cancer survivors on physical function and quality-of-life.
  II. To determine the most important behavioral variables for predicting physical activity adherence.
  III. To determine the most significant facilitators and barriers to adherence during the 12-week intervention.
  IV. To compare the thematic differences between high-adherence and low-adherence participants and qualitatively assess the strengths and weaknesses of the 12-week intervention.
  OUTLINE: Participants are randomized to 1 of 2 groups
  GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.
  GROUP II: Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.
  After completion of study, participants are followed up at 12 weeks.

Eligibility: Inclusion Criteria:
  -  Written informed consent form signed and dated by the subject
  -  English and/or Spanish speaking
  -  History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment
  -  Overweight (body mass index [BMI] >= 30)
  -  Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
  -  Medically capable of performing moderate intensity exercise
  Exclusion Criteria:
  -  Must not have engaged in a regular (> 3x/week, physical activity program in the last 6 months)
  -  Medical contraindication to exercise

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

Clinical trial: A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma

Summary: This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A is the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.

Detailed description: The study is a dose escalation study. The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) will be enrolled in patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.

Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Histological or cytological documentation of an advanced solid tumor
  -  Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission
  -  Subject must have evaluable, progressive, and measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
  -  Adequate bone marrow, liver, and renal function
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  For Part B (expansion) in subjects metastatic urothelial carcinoma:
  -  The patient's tumor has been evaluated and prospectively identified as having FGFR 1, 2, 3, or 4 genetic alterations.
  Exclusion Criteria:
  -  Patients who have received adequate prior treatment with a highly selective FGFR inhibitor
  -  Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
  -  Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)
  -  Patients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix
  -  Patients with glioblastoma multiforme
  -  Patient has a primary neoplasm of the brain or known uncontrolled metastases to the central nervous system (CNS).

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

Clinical trial: Advanced Methods for Cancer Detection by Vaginal Screening

Summary: This pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.

Detailed description: Most high grade ovarian cancers originate in the fallopian tubes. Since the lining of the fallopian tube opens into the uterine cavity cancer cells from ovarian/fallopian tube cancers can travel through the uterus to the cervix and vagina. Likewise, endometrial cancer cells shed through the cervix into the vagina. It may be possible to develop a screening test for ovarian and endometrial cancers by collecting vaginal cells.

Eligibility: Inclusion Criteria:
  Ovarian Cancer and Endometrial Cancer cases:
  1. Women age 19 or older.
  2. Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy.
  3. Give consent to access primary tumour tissue following surgery or biopsy.
  Healthy participants:
  1) Healthy women between the ages of 19 and 60.
  Exclusion Criteria:
  Ovarian Cancer and Endometrial Cancer cases:
  1. Women with self-reported, known pregnancy.
  Healthy participants:
  2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded.
  3. Women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible.
  4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study.
  5. Women with self-reported, known pregnancy.

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

Clinical trial: Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers

Summary: To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays.

Detailed description: Glycosylation is a widely utilized chemical modification of proteins and lipids in mammalian cells during which saccharide units are covalently attached to the target structures and then sequentially elongated and branched - reactions facilitated by a large number of various glycosyltransferases. Alterations in this process have been associated with malignant transformation. To clarify the critical role of glycosyltransferases, altered Mucins (MUC), and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases (including β-1,4-Galactosyltransferase 1 (B4GALT1), β-1,4-Galactosyltransferase 3 (B4GALT3), β-1,4-N-Acetyl-Galactosaminyl Transferase 3 (B4GALNT3), Polypeptide N-Acetylgalactosaminyltransferase 2 (GALNT2), Polypeptide N-Acetylgalactosaminyltransferase 6 (GALNT6), β1,4-N-acetylglucosaminyltransferase III (GlcNAcT-III), β1,4-N-acetylglucosaminyltransferase V (GlcNAcT-V), and Glycoprotein-N-Acetylgalactosamine 3-Beta-Galactosyltransferase 1 (C1GALT1), Mucins (including MUC1, MUC3, MUC15, and MUC20) and receptor tyrosin kinases (RTKs) family (including epidermal growth factor receptor (EGFR), Src, VEGFR, and c-Met) in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays, and compare them with clinicopathologic factors including outcome of the patients.

Eligibility: Inclusion Criteria:
  -  Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital
  Exclusion Criteria:
  -  Recurrence or non-operable patients

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

Clinical trial: STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

Summary: The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer


Eligibility: Inclusion Criteria:
  -  Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
  -  Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations
  Exclusion Criteria:
  -  Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
  -  Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
  -  Patients who underwent previous aortic lymphadenectomy
  -  Patients who received previous pelvic and/or aortic radiotherapy

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

Clinical trial: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=75 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sirolimus

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

Clinical trial: Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

Summary: This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed description: PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Eligibility: Inclusion Criteria:
  -  Age 18 and older
  -  patients who had a hysterectomy
  -  patient able to provide consent and complete questionnaire

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

Clinical trial: Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer

Summary: The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.

Detailed description: PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.

Eligibility: Inclusion Criteria:
  -  Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology)
  -  BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm
  -  Patients who pass standard clinical MRI screening procedures
  -  Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN
  -  Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN
  Exclusion Criteria:
  -  Allergy to FDG or gadolinium
  -  Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging
  -  Known kidney disease or poor renal function
  -  Pregnant

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

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant