araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246

Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.


Eligibility: Inclusion Criteria:
  -  Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
  -  Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
  -  At least a single measurable lesion
  -  Adequate organ function prior to registration
  -  Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
  -  ECOG performance status of 0 to 2
  Exclusion Criteria:
  -  Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
  -  Hypersensitivity to PLD or to any of the excipients
  -  Unable to undergo imaging by either CT scan or MRI
  -  Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
  -  Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
  -  Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Adipose Tissue Cellular Response to Exercise in Healthy Humans

Summary: The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.

Detailed description: Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.

Eligibility: Inclusion Criteria:
  -  Age: 18-40
  -  Body Mass Index: 20-27 kg/m2
  -  Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
  -  Women must have regularly occurring menses and must be premenopausal
  Exclusion Criteria:
  -  Blood pressure greater than 140/90 mm Hg
  -  Pregnant or lactating
  -  Evidence/history of cardiovascular or metabolic disease
  -  Medications known to affect lipid or glucose metabolism, or inflammation

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Study to Compare Pathologic Type, NIH and WHO Criteria,and Mechanism of GIST Malignant Transformation

Summary: Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment

Detailed description: 1. Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
  2. Organize the first multicenter prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
  3. Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.

Eligibility: Inclusion Criteria:
  -  All patients pathologically diagnosed with GIST during the period from 2017 to 2020
  Exclusion Criteria:
  -  Only have Biopsy diagnosis
  -  Only have Liver metastasis or peritoneal dissemination
  -  Received imatinib treatment before surgery

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

Summary: To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib

Detailed description: Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy.
  Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of <0.05 was considered statistically significant.

Eligibility: Inclusion Criteria:
  1. .Histopathological diagnosis of metastatic GIST.
  2. . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
  3. . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
  4. at least 1 month after surgery for imatinib treatment or sunitinib treatment.
  5. at least one imaging assessment was received after surgery.
  6. . Complete clinical data and follow-up data.
  Exclusion Criteria:
  1. . Before operation, he was treated with sunitinib
  2. . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
  3. . The treatment of imatinib or sunitinib after surgery was less than 1 month.
  4. . Incomplete clinical data or follow-up data.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

Summary: To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.


Eligibility: Inclusion Criteria:
  -  Age 18 years or older, at the time of acquisition of informed consent
  -  Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
  -  Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations
  -  imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: KRT-232 in Subjects With PMF, Post-PV MF, or Post-ET MF Who Have Failed a JAK Inhibitor

Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
  This study is a global, open-label Phase 2 study to determine the efficacy and safety of KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2 different doses and 2 different dosing schedules of KRT-232. In Part B of the study, patients will be treated at the recommended dose and schedule from Part A.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  -  High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  -  Failure of prior treatment with JAK inhibitor (Part A) or ruxolitinib (Part B)
  -  ECOG ≤ 2
  Exclusion Criteria:
  -  Prior splenectomy
  -  Splenic irradiation within 3 months prior to the first dose of KRT-232
  -  Active or chronic bleeding within 4 weeks prior to the first dose of KRT-232
  -  Prior MDM2 inhibitor therapy or p53-directed therapy
  -  Prior treatment with HDAC or BCL-2 inhibitors
  -  Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea.
  This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 3 arms with 2 different doses and 2 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of PV (WHO 2016)
  -  ECOG ≤ 2
  -  Part A: patients with and without splenomegaly are eligible
  -  Part A: patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon
  -  Part B: only patients with splenomegaly are eligible
  -  Part B: patients must be resistant or intolerant to hydroxyurea
  Exclusion Criteria:
  -  Diagnosis of post-PV myelofibrosis (IWG-MRT)
  -  Prior treatment with MDM2 inhibitors, p53-directed therapies, HDAC, BCL 2 inhibitors
  -  Splenic irradiation within 3 months prior to the first dose of study treatment
  -  Clinically significant thrombosis within 3 months of screening
  -  Grade 2 or higher QTc prolongation
  -  Part B: prior treatment with a JAK inhibitor

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST

Summary: This is a US, multicenter, open-label expanded access program to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.


Eligibility: Inclusion Criteria:
  1. Patient is ≥ 16 years of age.
  2. Diagnosis of unresectable or metastatic GIST
  3. The patient is not eligible for an ongoing study of avapritinib or cannot access an ongoing study of avapritinib.
  4. Patient has received 3 or more TKI therapies including imatinib, or the patient has GIST that carries a mutation in exon 18 of the PDGFRA gene (such as D842V).
  5. The patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow and endocrine, and is expected to tolerate therapy with a TKI.
  6. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
  Exclusion Criteria:
  1. Patients who have poor organ function as defined by one or more of the following laboratory parameters;
  1. Total bilirubin > 2 × ULN; or > 3 × ULN in the presence of Gilbert's Disease;
  2. Platelet count < 75 × 10^9/L.
  2. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
  3. Patient has had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of the first dose of avapritinib.
  4. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year prior to the first dose of program drug.
  5. Patient has a known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding.
  6. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
  7. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the randomization. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor, after pregnancy has been ruled out. Females of non- childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test.
  8. Women who are breast feeding.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Novel 3D Myeloma Organoid to Study Disease Biology and Chemosensitivity

Summary: The objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting of relapsed multiple myeloma and potentially other cancers.

Detailed description: Optimize the novel 3D organoid technique already used to recreate myeloma tumors in the Regenerative Medicine laboratory.
  Optimize cell viability of myeloma organoids to extend available time in culture by screening cell culture media cytokines and 3D extracellular matrix composition (current environment is able to maintain cells alive for up to 5-7 days to allow testing).
  Evaluate myeloma tumor markers at different time points of organoid life to confirm accurate tumor representation, identify genetic expression characteristics, unique mutations, and tumor-stroma interaction. This will give information of the tumor characteristics to learn about tumor biology and correlate with responses.
  Evaluate chemosensitivity on patient derived 3D organoids. Using myeloma patients marrow aspirate, evaluate live/kill rates of myeloma cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations.
  Using patient samples, evaluate differences in gene expression and cell markers of the myeloma cells that remained alive after chemotherapy exposure to better understand mechanisms of resistance.
  Validate the predictive value of the 3D organoid chemobiogram results compared with retrospective data of the donor s responses to the treatment used at that time point. This will compare in vivo/ex vivo responses and facilitate future personalized medicine. Chemobiogram is the report on chemosensitivity from the combinations tested much like an antibiogram.

Eligibility: Inclusion Criteria:
  -  Any participant who has multiple myeloma with no other ongoing blood cancer and will undergo a bone marrow biopsy as part of their routine care prior to receiving chemotherapy (both newly diagnosed and relapse disease).
  Exclusion Criteria:
  -  Any participant that does not have multiple myeloma.
  -  Any participant with other ongoing blood cancer.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Jejunoileal vs Gastric GIST in the Era of Imatinib.

Summary: Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.
  Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.


Eligibility: Inclusion Criteria:
  -  Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.
  Exclusion Criteria:
  -

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Summary: The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

Detailed description: TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.

Eligibility: Inclusion Criteria:
  1. Is equal to or greater than 18 years of age.
  2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
  3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
  5. Adequate baseline organ system function.
  6. Patients could receive treatment program from MTB (Molecular Tumor Board).
  7. No prior treatment with PARP combined with VEGFR inhibitions.
  8. Ability to understand and the willingness to provide a written informed consent document.
  Exclusion Criteria:
  1. Women who are pregnant or breastfeeding.
  2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  4. Active infection requiring systemic therapy.
  5. Patients unable to swallow orally administered medication.
  6. Prior treatment with PARP or VEGFR inhibitions.
  7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Relevance to patient case: not relevant