araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms

Summary: A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.

Detailed description: The investigators did an analysis from a prospectively maintained database of patients who underwent pancreatic resections or nonresective procedures for neoplasms of the pancreas at Sir Ganga Ram Hospital from 1995 to 2013 and using pathological reports and preoperative CT scan as the gold standard, the investigators identified 40 patients with PENs.

Eligibility: Inclusion Criteria:
  -  Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours
  Exclusion Criteria:
  -  Nonendocrine Pancreatic Tumours

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

Summary: This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

Detailed description: Iron overload and mechanisms inducing insulin resistance are reciprocally linked. Dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. Iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus.
  Serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome.
  Hypothesis:
  Measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of T2DM and clinically significant non-alcoholic fatty liver disease.

Eligibility: Inclusion Criteria:
  -  all
  Exclusion Criteria:
  -  lack of capacity for informed consent; vulnerable individuals

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

Summary: The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

Detailed description: An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC.
  -  Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
  -  Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
  -  Patient must be able to comply with the protocol
  Exclusion Criteria:
  -  Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
  -  Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
  -  Histologically confirmed small cell lung cancer or other metastatic tumors
  -  Patient with no histologic or cytological diagnosis.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: In Vitro Models of Liver and Pancreatic Cancer

Summary: The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the investigators hope to compare molecular and cellular biology of cancer cells with normal cells as well as potentially test the efficacy of current and future anti-cancer therapies.
  Samples will be collected from tissue that has been resected as part of the treatment for a patient diagnosed with liver, bile duct or pancreas cancer.


Eligibility: Inclusion Criteria:
  -  All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.
  Exclusion Criteria:
  -  Patients aged <18 or those who are unable to give informed consent.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

Summary: This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
  Gefitinib 250 mg will be administered orally daily.
  To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with Gefitinib
  8. Patients with a risk factor of interstitial lung disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

Summary: KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).
  Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.


Eligibility: Inclusion Criteria:
  1. age ≥ 20
  2. advanced, refractory cancer patients who failed standard of care (SOC)
  3. KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
  4. ECOG performance status of 0~2
  5. measurable or evaluable lesion per RECIST 1.1 criteria
  6. adequate marrow, hepatic, renal and cardiac functions
  -  Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
  -  Total serum bilirubin ≤ 1.5 x ULN
  -  Absolute neutrophil count(ANC) ≥ 1,500/uL
  -  Platelets ≥ 100,0000/uL
  -  Hemoglobin ≥ 9.0 g/dL
  7. provision of a signed written informed consent
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. history of major surgery or radiotherapy within 4 weeks
  4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
  5. known history of hypersensitivity to study drugs

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase 1 Study of BLU-554 in Patients With Hepatocellular Carcinoma

Summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU- 554 administered orally in patients with hepatocellular carcinoma (HCC). The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2) exploring both a once daily (qd) and twice daily (bid) dosing schedule.


Eligibility: Key Inclusion Criteria:
  -  Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines. Patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
  OR
  -  In Part 1 only, confirmed diagnosis of a relapsed or refractory advanced solid tumor other than HCC that has evidence of aberrant FGF19/FGFR4 pathway activity [e.g. tumor or blood/plasma alterations including, but not limited to, 11q13.1 locus (FGF19/CCND1 (cyclin D1)) amplification/copy number gain]
  -  Child-Pugh class A with no clinically apparent ascites
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
  -  For Part 2, all patients must have an FGF19 IHC result available. Only FGF19 IHC positive HCC patients will be eligible for Part 2 of the bid dosing schedule.
  Key Exclusion Criteria:
  -  Central nervous system metastases
  -  Platelet count <75,000/mL
  -  Absolute neutrophil count <1000/mL
  -  Hemoglobin <8 g/dL
  -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal (ULN)
  -  Total bilirubin >2.5 mg/dL
  -  International normalized ratio (INR) >2.3 or prothrombin time (PT) >6 seconds above control
  -  Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas

Summary: A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.

Detailed description: A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients. The study also includes a feasibility study to evaluate the role of intraoperative nCLE in the diagnosis and staging of pancreatic tumours. This part of the study will recruit a further 20 patients.
  Primary endpoint:
  Assess the diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts, compared to standard diagnostic modalities.
  Secondary endpoints:
  -  Assess the safety and efficacy of EUS-nCLE.
  -  Assess the impact of the Cellvizio nCLE system on the management of patients with pancreatic cysts.
  -  Develop and validate interpretation criteria for nCLE in the pancreas.
  -  Assess the diagnostic performance of nCLE in characterising and staging pancreatic tumours intraoperatively.

Eligibility: Inclusion Criteria:
  1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
  2. Pancreatic cystic tumour >1cm in size.
  3. ECOG performance status 0, 1 or 2.
  4. Estimated life expectancy of at least 12 weeks.
  5. Age >18 years.
  6. Capable of giving written informed consent.
  7. Has not has pancreatitis within the previous 3 months.
  8. Women of child-bearing potential must have a negative pregnancy test in the week before nCLE, AND be using an adequate contraception method, which must be continued for at least 1 week after nCLE.
  Exclusion Criteria:
  1. Acute pancreatitis in the last 3 months.
  2. Subject with multiple cysts
  3. Subjects for whom EUS-FNA or surgery are contraindicated
  4. Known allergy to fluorescein dye
  5. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
  6. Any psychiatric disorder making reliable informed consent impossible.
  7. Pregnancy or breast-feeding.
  8. ECOG performance status 3 or 4

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer

Summary: The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.


Eligibility: Inclusion Criteria:
  1. Advanced Pancreatic cancer patients with histological pathology confirmation
  2. Both gender, aged 18-70 year-old
  3. Bone marrow functioned well
  4. Renal function normal
  5. Liver function normal
  6. patients are voluntary, and willing to sign informed consent
  7. expected lifetime was at least 3 months
  Exclusion Criteria:
  1. With acute inflammation
  2. Accompanied with primary malignant tumor other than pancreas
  3. with autoimmune disease
  4. using corticosteroid or other suppress immune hormone treatment
  5. had transplant operation of vital organs
  6. active hepatitis
  7. HIV positive
  8. dysfunction in blood coagulation
  9. serious diseases in circulatory and respiratory systems
  10. pregnancy or breast-feeding women

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer

Summary: The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

Detailed description: The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.

Eligibility: Inclusion Criteria:
  1. Diagnosed as pancreatic cancer
  2. Between 20~90 years old
  3. ECOG 0-2
  4. Normal renal function
  5. Measurable tumor size (>1cm)
  Exclusion Criteria:
  1. Contraindication for MRI exam
  2. Claustrophobia
  3. Renal insufficiency
  4. Other malignancy
  5. Pregnancy and lactating women

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Treatment of Pancreatic Cancer With Abraxane

Summary: This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

Detailed description: This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
  A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
  Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.

Eligibility: Inclusion Criteria:
  1. Metastatic pancreatic carcinoma
  2. Age > 18 years
  3. Signed Informed Consent
  4. Normal hepatic, renal and Bone Marrow functions
  Exclusion Criteria:
  1. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils < 1,5 x 10^9/L

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Summary: This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.


Eligibility: Inclusion Criteria:
  -  Adult participants 18 to 75 years of age
  -  Locally advanced or metastatic pancreatic cancer
  Exclusion Criteria:
  - Prior chemotherapy for pancreatic cancer

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Summary: The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Patient had received ≤ 1 prior systemic chemotherapy regimens;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  Exclusion Criteria:
  -  Prior received ≥2 systemic chemotherapy regimens;
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  Histologically confirmed small cell lung cancer or other metastatic tumors;
  -  Patient with no histologic or cytological diagnosis;

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Pancreatic Neuroendocrine Tumor：Factor of Surgery Influencing Survival

Summary: Investigator determined the factor of surgery associated with the survival of pancreatic neuroendocrine tumor.

Detailed description: The variables including clinical characteristics, surgical data and pathological findings are examined by univariate and multivariate analyses.

Eligibility: Inclusion Criteria:
  -  The patients with pancreatic neuroendocrine tumor underwent pancreatectomy
  Exclusion Criteria:
  -  The patients with pancreatic neuroendocrine tumor did not undergo pancreatectomy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

Summary: A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).


Eligibility: Inclusion Criteria:
  -  histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.
  informed consent
  Exclusion Criteria:
  -  cystic tumor
  age under 18

Relevance to patient case: not relevant