araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: A Study of Apatinib Combined With Temozolomide in Patients Witn Advanced Melanoma

Summary: 30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.

Detailed description: In this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. The therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib, 500 mg, qd, po, d1-28, Every 28 days for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. So we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.

Eligibility: Inclusion Criteria:
  -  Age 18-70 years old；
  -  ECOG performance scale 0-1；
  -  Life expectancy of more than 3 months；
  -  Histologically or cytologic confirmed melanoma；
  -  Temozolomide has not been previously treated；
  -  Patients who have failed at least one systemic treatment regimen： including but not limited to patients receiving immunotherapeutics such as PD-1 monoclonal antibodies, PDL-1 monoclonal antibodies, ipilimumab, C-kit inhibitors, Braf inhibitors, and molecular targeted drugs.
  -  For results of blood routine test and biochemical tests： Hgb＞100g/L, ANC＞2.0×109/L, PLT＞100×109/L, Serum Total bilirubin ≤ 1.5 X UNL, ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）, Serum Creatine ≤ 1.5 x UNL；
  -  Informed consent；
  -  Willingness and ability to comply with scheduled visits.
  Exclusion Criteria:
  -  Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)；
  -  With ≥grade 2 coronary heart disease, arrhythmia (including QTc interval prolongation male ≥450 ms, women ≥470 ms)；
  -  Imaging studies have shown that the tumor has been infringing on an important perivascular or when the researcher determines that the patient's tumor has a high risk of fatal hemorrhage during treatment；
  -  Abnormal Coagulation (INR>1.5, PT>UNL+4 seconds), with tendency of bleed or receiving the therapy of thrombolysis or anticoagulation.；
  -  Urine protein ≥++ or confirmed ＞1.0 g by the 24h quantity；
  -  Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures；
  -  A history of psychotropic substance abuse and can not be abstinent or mental disorders ；
  -  There are serious concomitant diseases that endanger patient safety or affect the patient in completing the study；
  -  Patients participating in other clinical trials simultaneously；
  -  Other situations that the researchers considered unsuitable for this study；
  -  Confirmed brain metastasis.

Relevance to patient case: possibly relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Summary: This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.

Detailed description: The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10^6U/m^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.

Eligibility: Inclusion Criteria:
  1. Age more than 18 years;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  3. Pathologically confirmed diagnosis of mucosal melanoma;
  4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
  5. No prior systemic adjuvant therapy or regional radiotherapy;
  6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
  7. Normal bone marrow function; and adequate liver and renal function [including white blood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].
  Exclusion Criteria:
  1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
  2. Incomplete resection or primary tumor unable to be resected;
  3. A second cancer diagnosis;
  4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
  5. Severe depression; and pregnant or lactating female.

Relevance to patient case: possibly relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

Summary: AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Detailed description: AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Eligibility: Inclusion Criteria:
  -  At least 20 years of age
  -  Patients who were in the AZD9291 Early Access Program
  -  Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents
  -  Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018
  -  Patients agree to provide the written informed consent or the informed consent is waived by IRB.
  Exclusion Criteria:
  • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Summary: In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.


Eligibility: Inclusion Criteria:
  1. T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria.
  2. Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
  3. Age is not limited. Both male and female are eligible.
  4. Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
  5. Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.
  Exclusion Criteria:
  1. Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
  2. Isolated extramedullary relapsed leukemia.
  3. With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention

Summary: The proposed study aims to increase HPV screening behaviors in Jamaican women by examining the acceptability of HPV Deoxyribonucleic Acid (DNA) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.


Eligibility: Inclusion Criteria:
  -  Jamaican women, aged 30 to 65.
  Exclusion Criteria:
  -  Women who report having had a hysterectomy,
  -  have had a history of cervical cancer,
  -  Women who are currently up-to-date on cervical cancer screening (have had a Pap in the last 3 years or have had a Pap smear/HPV co-test within the past 5 years),
  -  Adults unable to consent, children, pregnant women and prisoners.

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Summary: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

Detailed description: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
  GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Eligibility: Inclusion Criteria:
  1. written informed consent
  2. 19 years or older
  3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
  4. high EGFR amplification
  5. available archive tumor sample(s)
  6. Karnofsky performance status (KPS) > 70
  7. life expectancy > 3 months
  8. adequate end-organ function
  9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)
  Exclusion Criteria:
  1. patients who had EGFR target agent(s) before screening
  2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
  3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
  4. patients who had investigation drug(s) within previous 4 weeks
  5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
  6. patients who had severe infection within previous 4 weeks
  7. HIV infection
  8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
  9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
  10. pregnancy or breast-feeding

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

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: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

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: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

Summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS reminder.


Eligibility: Inclusion Criteria:
  -  women from 30 to 66 years old
  -  women living in french territorial division 37 ("Indre-et-Loire")
  -  women with a mobile phone in database
  -  women who do not perform a pap smear in the last 4 years
  -  women who do not answer to a first "invitation" letter to perform a pap smear
  Exclusion Criteria:
  -  STOP SMS
  -  HPV cervical pathology during treatment
  -  Hysterectomy including cervix

Relevance to patient case: not relevant
Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

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: possibly relevant
Patient case: 56-year-old female with gastrointestinal stromal tumor; genetic feature: PDGFRA (D842V)

Clinical trial: A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

Summary: The objectives of the study are:
  1. Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein.
  2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
  3. Analysis of patient's blood samples for the detection of activated kinases.


Eligibility: Inclusion Criteria:
  Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories:
  1. previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha.
  2. not previously treated but with documented Fip1L1-PDGFRA fusion protein
  Exclusion Criteria:
  -  Other diseases associated with hypereosinophilia
  -  Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
  -  ECOG performance status >3
  Other protocol-defined exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 56-year-old female with gastrointestinal stromal tumor; genetic feature: PDGFRA (D842V)

Clinical trial: Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

Summary: The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.


Eligibility: Inclusion Criteria:
  -  Diagnosis of histological confirmed GIST
  -  Had prior imatinib mesylate therapy
  -  Has at least 1 measurable leasion by modified RECIST
  Exclusion Criteria:
  -  Central nervous system tumor involvement requiring treatment
  -  History of myocardial infraction
  -  Uncontrolled hypertension

Relevance to patient case: not relevant
Patient case: 56-year-old female with gastrointestinal stromal tumor; genetic feature: PDGFRA (D842V)

Clinical trial: Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)

Summary: The primary objectives of the study are:
  -  Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
  -  Recommend a dose for subsequent studies of IPI-504

Detailed description: IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. In patients with GIST, mutations in the tyrosine kinase receptor Kit play a critical role in the pathogenesis of this disease. Inhibition of Kit signaling with the tyrosine kinase inhibitor Imatinib (IM) is a very effective treatment for GIST patients. However, new mutations arise in Kit conferring resistance to IM treatment which results in disease progression. Kit is a client protein of Hsp90 and is sensitive to IPI-504. In Soft Tissue Sarcomas, there may be genetic abnormalities that lead to the expression of certain proteins that drive the growth of cancer. These cancer-driving proteins may be stimulated by HSP90. This provides a scientific rationale for Phase 1 clinical testing of IPI-504 in patients with advanced GIST and STS who have failed prior therapies.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed diagnosis of GIST or STS
  -  Failed prior therapies
  -  ECOG performance status of 0-2
  -  Ability to adhere to the study visit schedule and all protocol requirements
  Exclusion Criteria:
  -  Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor
  -  Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment
  -  Concurrent radiation therapy is not permitted
  -  Concurrent treatment with any agent that alters CYP3A activity
  -  Concurrent treatment with any agent that may prolong the QTc interval
  -  Myocardial infarction or active ischemic heart disease within 6 months
  -  History of arrhythmia
  -  Baseline QTc >450
  -  Grade 3 or greater peripheral neuropathy
  -  Renal insufficiency, serum creatinine >1.5 x ULN
  -  Platelets < 100,000 mm3
  -  AST and / or ALT > 2.5 x ULN
  -  ANC <1,500 cells/mm3
  -  Alkaline phosphatase > 2.5 x ULN
  -  Amylase and lipase > 1.5 x ULN
  -  Hemoglobin < 9.0 g/dL

Relevance to patient case: not relevant