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

Clinical trial: Endometrial Injury and Single Embryo Transfer

Summary: Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.

Detailed description: Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.

Eligibility: Inclusion Criteria:
  -  woman age under 35 years
  -  history of primary infertility
  -  normoresponder (antral follicle count 5-10 in one ovary in early follicular phase
  -  having grade I or II embryos for transfer
  -  agree to undergo endometrial biopsy during the COH cycle. All patients were stimulated with luteal phase long protocol.
  Exclusion Criteria:
  -  endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), any systemic disease, collagen disorder, hypercholesterolemia, sickle cell anemia, and a history of neoplasm; -high risk for or history of OHSS
  -  using any concurrent medication (e.g., insulin-sensitizing drugs, and GnRH antagonists)
  -  patients who did not proceed to follicle retrieval
  -  severe male infertility requiring TESA/TESA
  -  mullerian tract anomalies
  -  a history of endometrial instrumentation or surgery within a month of the study
  -  not agree to undergo endometrial biopsy during the COH cycle.

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

Clinical trial: Follow-up of Endometrial Cancer Patients

Summary: The present study is conducted, to elucidate the value of follow-up examinations in endometrial cancer patients. Specifically the objective is to compare hospital-based follow-up examinations with instruction in self-referral in stage I endometrial cancer patients.
  The investigators hypothesize that the intervention, instruction in self-referral, will:
  -  reduce fear of recurrence
  -  improve quality of life
  -  improve cost-utility
  -  not affect disease-free survival.


Eligibility: Inclusion Criteria:
  -  Diagnosed with stage I Endometrial Cancer
  Exclusion Criteria:
  -  Dementia or other mental/cognitive impairment
  -  Illiterate in Danish
  -  Treated with adjuvant chemo- and/or radiotherapy
  -  high risk histology
  -  grade 3
  -  follow-up for other gynecologic malignancy

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

Clinical trial: Factors Affecting the Prognosis of Patients With Endometrial Cancer

Summary: Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I & II, the most histology is still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.
  Most patients has good outcome of endometrial cancer because their surgical stage is belonged to "early stage". However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.
  Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential "sandwich" therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.
  The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.


Eligibility: Inclusion Criteria:
  1. Time interval: from 1991 to date.
  2. Comprehensive surgical staging or debulking procedure.
  3. All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.
  Exclusion Criteria:
  1. Not comprehensive staging/debulking procedure.
  2. Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

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

Clinical trial: A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

Summary: This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.


Eligibility: Inclusion Criteria:
  -  Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.
  Additional surgical staging procedures are permissible but not required.
  -  Risk factors: patients must fit one of the following:
  -  Pelvic lymph node metastases
  -  Paraaortic lymph node metastases
  -  Grade 3 with myometrial invasion >50%
  -  With stromal invasion of cervix
  -  Known extrauterine disease (excluding second primary) confined to the pelvis.
  -  High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,
  -  No known gross residual disease, or distant metastases.
  -  Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.
  -  White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.
  -  Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal.
  -  No medical contraindications to chemotherapy, or radiation therapy.
  -  Study-specific signed informed consent.
  Exclusion Criteria:
  -  Prior pelvic radiation therapy.
  -  Positive peritoneal cytology only for stage IIIa (FIGO 1998).
  -  With history of other malignancies less than 5 years.
  -  With gross residual disease, or distant metastases.
  -  With endometrioid endometrial carcinoma and no risk factors:
  -  with myometrial invasion <50%
  -  Grade 1~2, with myometrial invasion >50%
  -  With serious internal diseases which affect designed treatment
  -  With psychotic disorders

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

Clinical trial: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility: Inclusion Criteria:
  -  KRAS and NRAS wild type metastatic colorectal cancer
  -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  -  Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  -  Prior radiation to the pelvis or abdomen
  -  Patients with history of interstitial lung disease.

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

Clinical trial: Neratinib HER Mutation Basket Study (SUMMIT)

Summary: This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  -  Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the Fibrolamellar Carcinoma cohort.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER tyrosine kinase inhibitor (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Clinical trial: Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator

Summary: Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.


Eligibility: Inclusion Criteria:
  -  Subjects who planned to undergo cataract removal by phacoemulsification
  -  Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry
  Exclusion Criteria:
  -  Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
  -  a history of intraocular or corneal surgery and ocular trauma
  -  biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
  -  contact lens wearer

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

Clinical trial: Endometrial Cancer Biomarker Changes Following Exposure to Metformin

Summary: The investigators will explore the chemopreventive role of metformin. The purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.

Detailed description: Aim 1 To determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue.
  Aim II To compare specified biomarkers in each endometrial cancer patient before and after receiving metformin. Our goal is to compare the following biomarkers in each patient before and after metformin administration: Ki-67, TUNEL assay for apoptosis level, phosphor-AMPK, phosphor-IGF-1R, phosphor-IRS1, phospho-Akt, phospho-S6, phosphor-mTOR, pACC.
  All patients diagnosed with endometrial cancer presenting to the Jewish General Hospital for surgical treatment will be invited to participate.

Eligibility: Inclusion Criteria:
  -  Have a confirmed diagnosis of endometrial cancer based on an endometrial sampling though biopsy or dilatation and curettage
  -  Must be able to undergo appropriate surgical staging for endometrial cancer
  -  Must consent to be in the study and must have signed and dated an IRB-approved consent form conforming to government and institutional guidelines
  Exclusion Criteria:
  -  Patients with a contraindication to receiving metformin treatment
  -  Patients with cognitive impairment
  -  Renal or hepatic functioning > 125% upper limit of normal
  -  Currently on medications for metabolic diseases, such as diabetes mellitus
  -  History of lactic acidosis
  -  Treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine
  -  History of chronic alcohol abuse

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

Clinical trial: Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.

Summary: Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.
  State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
  In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
  Aim of this study:
  There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Detailed description: Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.
  State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
  In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
  Aim of this study:
  There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Eligibility: Inclusion Criteria:
  -  suspected ovarian cancer
  -  verified ovarian cancer
  Exclusion Criteria:
  -  pregnant
  -  incapacitated persons

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

Clinical trial: Women With Asymptomatic Endometrial Hyperplasia

Summary: The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.


Eligibility: Inclusion Criteria:
  -  asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
  Exclusion Criteria:
  -  postmenopausal bleeding

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

Clinical trial: Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer

Summary: The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.


Eligibility: Inclusion Criteria:
  -  Age 18-80 years
  -  Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Patients must have adequate:
  -  Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
  -  Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) [CKD-EPI Formula] ≥ 60 mL/min
  -  Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
  -  Physically able to undergo surgery
  -  Written informed consent
  Exclusion Criteria:
  -  Confirmed gynaecological malignancy
  -  Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
  -  Patients who are pregnant or lactating
  -  Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
  -  HIV positive
  -  Previous bariatric surgery

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

Clinical trial: Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.

Summary: An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
  -  Male or female and over 18 years of age
  -  Must have a life expectancy of at least three months
  -  World Health Organization Performance Status of 0 to 1
  -  Given written conformed consent
  Exclusion Criteria:
  -  Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
  -  History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
  -  Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
  -  Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
  -  Females who pregnant, planning to become pregnant or lactating
  -  Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
  -  Previously received G17DT treatment
  -  Haemoglobin (Hb) < 10.0 g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L

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

Clinical trial: Application of Integrated MR-PET in Patients With Gynecologic Cancers

Summary: In this prospective cohort study, patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220. Patients will undergo image study before and after treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor treatment response and predict treatment outcome will be investigated.


Eligibility: Inclusion Criteria:
  1. Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
  2. Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).
  3. Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.
  Exclusion Criteria:
  1. Age <20 or >90 years old
  2. Contraindication for MRI:
  3. Contraindication for MR contrast medium (Cre > 2.0)
  4. History of other malignancy
  5. Prior arthroplasty of hip or pelvic bone surgery with metallic fixation (may cause artifacts on MRI)
  6. Pregnant or lactating women

Relevance to patient case: not relevant