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

Clinical trial: Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Summary: The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

Detailed description: We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Eligibility: Inclusion Criteria:
  -  Indication to carry out diagnostic hysteroscopy
  -  Agrees and is suitable for outpatient/office hysteroscopy
  Exclusion Criteria:
  -  Failed outpatient/office hysteroscopy

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

Clinical trial: Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of:
  -  Advanced solid tumor that is no longer responding to therapies OR
  -  Advanced or recurrent endometrial carcinoma OR
  -  Advanced or recurrent ovarian carcinoma OR
  -  Unresectable (Stage IIIB or IV) NSCLC
  -  ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)
  -  Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
  -  At least 18 years old
  -  Both men and women must practice adequate contraception
  -  Informed consent
  Exclusion Criteria:
  -  Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
  -  Known allergy or hypersensitivity to any of the components of the treatment formulations
  -  Taking oral corticosteroids chronically or > 1 mg/day warfarin
  -  Not recovered from the toxic effects of prior therapy
  -  History of diabetes mellitus.
  -  Uncontrolled intercurrent illness
  -  Pregnant or breastfeeding
  -  Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
  -  HIV positive
  -  Diagnosis of another malignancy may exclude subject from study

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

Clinical trial: Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with endometrial cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of endometrial cancer cases.
  -  To define the proportion of endometrial cancer incidence attributable to mutations in known predisposing genes such as MSH2 and MLH1.
  -  To determine the risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers.
  -  To examine the effect of nongenetic risk factors in mutation carriers.
  -  To determine the pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers.
  -  To establish whether mutations at other loci may predispose to endometrial cancer by comparing the frequency of alterations in endometrial cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire. The questionnaire will request identifying information about the patient's first-degree relatives.
  Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the endometrial cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of endometrial cancer within the past 5 years
  -  Identified in any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Oxford
  -  Trent
  -  West Midlands
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  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: Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene

Summary: This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.

Detailed description: The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible in case of a regulatory inspection of the 303 protocol. Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP) approval, and enrollment could not be met without the inclusion of these subjects. The study was not terminated due to safety concerns.

Eligibility: Inclusion Criteria:
  -  Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
  -  Has completed 24 months of treatment.
  -  Was at least 80% compliant with study drug administration.
  Exclusion Criteria:
  -  Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
  -  Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)

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

Clinical trial: Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy

Summary: The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine preoperative facts affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to laparotomy.

Detailed description: All patients that are surgical candidates with endometrial cancer will be screened for this study. Two measurements from each eye will be taken in the following positions: awake at rest, supine before induction, after induction on anesthesia, after insufflation of abdomen with CO2 in supine position, in trendelenburg position, in deep trendelenburg position,at the end of procedure,prior to awakening in supine position and one last reading 45-60 min after awakening in supine position. The time, blood pressure, heart rate, peak airway pressure, plateau airway pressure, end tidal desflurane, end tidal CO2, total IV fluids administered, and blood loss.

Eligibility: Inclusion Criteria:
  -  Endometrial Cancer Surgery
  Exclusion Criteria:
  -  Not a surgical candidate

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

Clinical trial: Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants

Summary: RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.
  PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.

Detailed description: OBJECTIVES:
  -  Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants.
  -  Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer.
  OUTLINE: This is a pilot study.
  Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay.
  PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.

Eligibility: Inclusion Criteria:
  -Meets 1 of the following criteria:
  -  Diagnosis of metastatic cancer including, but not limited to, any of the following:
  -  Stage IV non-small cell lung cancer
  -  Extensive-stage small cell lung cancer
  -  Metastatic testicular cancer
  -  Stage IV breast carcinoma
  -  Stage III or IV ovarian carcinoma
  -  Stage IV endometrial carcinoma
  -  Stage IV prostate carcinoma
  -  Stage IV colorectal or pancreatic cancer
  -  Stage IV renal cancer
  -  Stage III or IV non-Hodgkin's lymphoma
  -  Stage IV bladder cancer
  -  Stage III multiple myeloma (Salmon-Durie staging)
  -  Metastatic melanoma
  -  Metastatic sarcoma
  -  Healthy participant, meeting the following criteria:
  -  No prior cancer
  -  Over 50 years of age
  Exclusion Criteria:
  -  Serious medical or psychiatric condition that would preclude study compliance
  -  Chemotherapy or radiotherapy within the past 3 months (patient)
  -  Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)

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

Clinical trial: Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Summary: The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

Detailed description: Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.

Eligibility: Inclusion Criteria:
  -  Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
  -  Women with an intact uterus.
  -  No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
  -  Endometrial thickness ≤ 5 mm.
  Exclusion Criteria:
  -  Submucosal fibroid/s that applying pressure and affecting endometrial thickness
  -  Other medication that could affect estrogenic state.

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

Clinical trial: New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma

Summary: The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

Detailed description: DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Eligibility: Inclusion Criteria:
  -  Age range 14-75 years old
  -  Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
  -  ECOG performance status less than 2
  -  Life expectancy of more than 3 months
  -  Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Serious uncontrolled diseases and intercurrent infection
  -  The evidence of CNS metastasis
  -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

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

Clinical trial: Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility: Inclusion Criteria:
  1. Female presenting with metastatic breast cancer.
  2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
  3. HER2 and HR status must have been determined.
  4. Patients must have HER2 negative breast cancer.
  5. Patients must have a documented disease progression as define by RECIST at baseline.
  6. Patients with HR+ disease:
  -  Must have received at least one prior endocrine therapy in the metastatic setting.
  -  Must have received no more than three lines of chemotherapy in the metastatic setting.
  7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
  Exclusion Criteria:
  1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  -  History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
  -  Clinically significant resting bradycardia (< 50 beats per minute).
  -  LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
  3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Sentinel Node and Endometrial Cancer

Summary: The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

Detailed description: To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Eligibility: Inclusion Criteria:
  -  patient over 18 years old with a surgery planned for endometrial cancer
  -  endometrial cancer proved by biopsy
  -  early stage of endometrial cancer (FIGO stage 1-2)
  -  without contraindication to surgery
  -  inform consent signed
  -  affiliated to general health system
  Exclusion Criteria:
  -  endometrial cancer FIGO stages 3-4
  -  previous history of surgery modifying lymphatic drainage (conization myomectomy)
  -  pregnant women or breast feeding

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

Clinical trial: Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

Summary: This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.
  Once the MTD has been defined, the MTD expansion part will be opened for enrollment.


Eligibility: Inclusion Criteria:
  All patients:
  -  Histologically-confirmed advanced solid tumors
  -  Progressive, recurrent unresectable disease
  -  World Health Organization (WHO) Performance status ≤ 2
  -  No history of primary brain tumor or brain metastases
  MTD Expansion part:
  -  Histologically-confirmed advanced solid tumors
  -  Progressive, recurrent unresectable disease
  -  World Health Organization (WHO) Performance status ≤ 2
  -  No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months
  -  Patients with genetic or molecular alteration of the PI3K pathway
  Exclusion Criteria:
  -  Prior treatment with a PI3K inhibitor
  -  History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation
  -  No clinically manifest diabetes mellitus (treated and/or with clinical signs)
  -  No acute or chronic renal disease
  -  No acute or chronic liver disease
  -  No acute or chronic pancreatitis
  -  No unresolved diarrhea
  -  No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
  -  No acute myocardial infarction or unstable angina pectoris within the past 3 months
  -  Not pregnant or nursing and fertile patients must use barrier contraceptives
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: The Effects of the Endocrine System on Endometrial Cancer

Summary: Endometrial cancer usually begins in the endometrium, which is the tissue lining of the uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260 deaths from the disease every year. Most affected women are aged between 50 and 70 years. The purpose of this study is to investigate the possible role of the endocrine system in the regulation of human endometrial cancer. By looking at the laboratory results of people with endometrial cancer and also those without endometrial cancer we hope to gain a better understanding of how endometrial cancer develops and progresses. This may lead to the development of new, effective therapies for endometrial cancer.


Eligibility: Inclusion Criteria:
  -  women aged 18 years or older
  -  having a hysterectomy for the treatment of endometrial cancer, fibroids, chronic pelvic pain or abnormal uterine bleeding
  -  have provided informed consent

Relevance to patient case: not relevant