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

Clinical trial: Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Summary: The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.


Eligibility: Inclusion Criteria:
  -  Signed informed consent prior to any procedures
  -  Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
  Exclusion Criteria:
  -  Patient having out of range laboratory values defined as:
  -  Creatinine clearance < 40 mL/min
  -  Total bilirubin > 1.5 x ULN
  -  Absolute neutrophil count < 1.0 x 109/L
  -  Hemoglobin (Hgb) < 9 g/dL
  -  Impaired cardiac function or clinically significant cardiac disease
  -  Active autoimmune disease
  -  Malignant disease, other than that being treated in this study.
  -  Presence of ≥ CTCAE Grade 2 toxicity due to prior cancer therapy.
  -  Pregnant or lactating women
  Other protocol-defined inclusion/exclusion may apply.

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

Clinical trial: The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Summary: Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of endometrial cancer
  -  Clinical stage I or II
  Exclusion Criteria:
  -  Contraindications for operation (hematological or coagulation disorders)
  -  Advanced stage
  -  Pregnancy or puerperium
  -  Fertility preserving surgery

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

Clinical trial: Observational Study on Endometrial Stromal Tumors

Summary: Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Detailed description: Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options.
  This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices.
  The study will also review the diagnosis by a central expert pathologist in order to its confirmation

Eligibility: Inclusion Criteria:
  -  patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014
  -  Informed consent signature
  Exclusion Criteria:
  -  patients with different diagnosis from EST

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

Clinical trial: Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.

Summary: Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

Detailed description: This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. There are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the Pathology clinic of Kayseri Training and Research Hospital archives.

Eligibility: Inclusion Criteria:
  -  diagnosed endometrial cancer
  -  diagnosed endometrial hyperplasia
  Exclusion Criteria:
  -  diagnosed cancer except endometrial cancer

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

Clinical trial: Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Summary: Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only.
  Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.
  This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage).
  Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs.
  This program will focus on uterine cancer (both cervix and corpus).


Eligibility: Inclusion Criteria:
  -  Age>18 years
  -  Endometrial or cervical cancer
  Exclusion Criteria:
  -

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

Clinical trial: The Maintenance Treatment of UFT in Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  -  ECOG PS 0-2
  -  At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
  -  Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)
  Exclusion Criteria:
  -  Receiving more or more than 2 regimens of chemotherapy
  -  Pregnant or lactating women
  -  Concurrent cancer
  -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  -  Neuropathy, brain, or leptomeningeal involvement
  -  Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
  -  Uncontrolled significant comorbid conditions and previous radiotherapy

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

Clinical trial: Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Summary: The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Detailed description: The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.
  Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

Eligibility: Inclusion Criteria:
  -  Clinical stage I endometrial cancer
  -  Laparoscopic operation
  Exclusion Criteria:
  -  post-operative oncologic follow-up < 12 months
  -  extra-uterine evidence of disease

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

Clinical trial: Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer

Summary: The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and to investigate its correlation impact with progression-free survival (PFS), and clinicopathological features including microsatellite instability and quantified stromal and intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)


Eligibility: Inclusion Criteria:
  -  All patients consecutively enrolled from January 2004 to December 2014 treated for Endometrial cancer
  -  Stage III-IV endometrial cancer with available tissue blocks, including biopsies, hysterectomy specimens and resections of metastatic foci
  Exclusion Criteria:
  -  A patient record captured outside the time frame from January 2004 to December 2014

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

Clinical trial: K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Summary: The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
  2. Progressive disease who failed to previous standard treatment.
  3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
  4. Eastern Cooperative Oncology Group performance status 0 or 1
  5. Able to take medications orally
  6. Adequate organ function
  7. A life expectancy of at least 60 days
  Exclusion Criteria:
  1. Previous treatment with anti-PI3K or AKT directed therapies
  2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
  3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
  4. Current evidence of retinopathy that requires ophthalmological therapy.
  5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
  6. Treatment with any of the following within the specified time frame prior to study drug administration:
  -  Major surgery within prior 4 weeks
  -  Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
  -  Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
  7. A serious illness or medical condition(s)
  8. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
  9. Patients with the risk of hypokalemia
  10. Receiving oral steroid medication.
  11. Pregnant or lactating female

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

Clinical trial: Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

Summary: This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
  SECONDARY OBJECTIVES:
  I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
  TERTIARY OBJECTIVES:
  I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
  II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
  OUTLINE:
  Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
  After completion of study, patients are followed up for 16 weeks.
  After completion of study, patients are followed up for 16 weeks.

Eligibility: Inclusion Criteria:
  -  Clinical stage I EC
  -  Low grade disease positive for estrogen and progesterone receptors
  -  Body mass index (BMI) >= 30 kg/m^2
  -  No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
  -  Self ambulatory and without use of assistive walking devices
  -  Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
  -  Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
  -  Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
  Exclusion Criteria:
  -  Patients with metastatic disease
  -  BMI =< 29.9 kg/m^2
  -  History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
  -  Is not self ambulatory and relies on the use of assistive walking devices
  -  Is a candidate for immediate hysterectomy, following evaluation by a physician
  -  In judgement of a physician, is not a candidate for progestin agents

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

Clinical trial: The LD Lync Study - Natural History Study of Genetic Lipodystrophy Syndromes

Summary: Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients.
  In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA, PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA); autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1) have been identified. However, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality.
  To overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic lipodystrophy syndromes. Patients will be assessed on a yearly basis for approximately 4 years to collect robust clinical, metabolic, morbidity and mortality data. Medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. Clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of genetic lipodystrophy Supportive data: 1) Presence of biallelic known disease-causing variants in the genes for autosomal recessive lipodystrophy syndromes; 2) Presence of a known (or de novo loss of function) disease-causing variant in the genes for autosomal dominant lipodystrophy syndromes.
  Exclusion Criteria:
  -  HIV-infected patients with lipodystrophy
  -  Drug-induced lipodystrophy

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

Clinical trial: Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

Summary: The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.

Detailed description: Endometrial cancer (EC) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. The incidence of EC is higher in high-income countries, but it has been increasing in low- and middle-income countries.
  The main risk factors for EC include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. Obesity is recognized as a major risk factor for many cancers, including EC. Multiple mechanisms related to obesity are probably involved in the carcinogenesis of EC. Among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. These estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (SHBG) in the liver. Insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of EC.
  Although the incidence of EC is remarkable, insufficient data has addressed the impact of obesity on EC outcomes. Since about 70% of women diagnosed with endometriod EC are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women.
  Sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. However, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. Studies assessing nutritional status and lifestyle before and after EC diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

Eligibility: Inclusion Criteria:
  -  endometrial cancer patients undergoing surgical treatment
  Exclusion Criteria:
  -  previous oncologic treatment
  -  cancer stage IV according to the International Federation of Gynecology and Obstetrics (FIGO)
  -  patients who report physical activity over 150 minutes/week of moderate or vigorous intensity
  -  individuals with decompensated diabetes mellitus or hypertension
  -  patients who have a contraindication to physical activity.

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

Clinical trial: Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer

Summary: Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035.
  The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management.
  The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity.
  The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.


Eligibility: Inclusion Criteria:
  -  postmenopausal patient.
  -  patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)
  Exclusion Criteria:
  -  patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.

Relevance to patient case: not relevant