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

Clinical trial: Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study

Summary: Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study

Detailed description: 1. Objectives The study will be performed to develop the integrated analytical methods of genomic data and clinical data and the bio-control network analysis, through which knowledge-based integrated analysis system can be developed and then biomarker for early diagnosis and treatment of pancreatic cancer and bile duct cancer, and finally the customized disease management system. Also, it is to confirm the effectiveness of diagnostic chip for research purpose by applying pancreatic/bile duct cancer-specific biomarker, miRNA, found through the integrated analysis of genomic data and clinical data of patients with pancreatic/bile duct cancer to the blood of patients with pancreatic/bile duct cancer.
  2. Effective evaluation method
  The discrimination and calibration for algorithm through the diagnostic chip of each cancer type will all be examined using 10-fold cross-validation (100 repetitions). In the 10-fold cross-validation, the data is randomly divided into 10 same sized data, among which 9 are used in making a model for training and the remaining 1 is applied for test, and this process is randomly and independently repeated for 100 times.
  The 10-fold cross-validated AUC is calculated to see the discrimination of diagnostic chip of each cancer type, and the 95% confidence interval is presented by non-parametric method.
  The 10-fold cross-validated calibration plot is presented to see the calibration of diagnostic chip of each cancer type. The calibration plot visually demonstrate the degree of prediction by comparing the prediction probability of each group and the ratio of actual cancer patients after listing the prediction probability in the order and dividing it with regular intervals.
  Then, for the same subjects, the AUC of the CA 19-9, the existing cancer diagnostic tool, is calculated and the 95% confidence interval is presented. To compare the diagnostic chip of each cancer type and the AUC of CA 19-9, p-value is calculated by non-parametric method of 10-fold cross-validated AUC.

Eligibility: Inclusion Criteria:
  -  Patients with histologically or cytologically diagnosed pancreatic cancer or bile duct cancer
  -  Patient age: 20~80 years old
  -  Patients who voluntarily determined to participate in the clinical trial and signed the informed consent for compliance
  -  Korean race
  Exclusion Criteria:
  -  Patients with previous history of chemotherapy or radiation therapy for pancreatic cancer and/or bile duct cancer
  -  Patients who had treatment or surgery for cancer of other organ within 5 years before the clinical trial

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 Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable

Summary: This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.


Eligibility: Inclusion Criteria:
  -  Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection)
  -  Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma
  -  Written informed consent obtained prior enrollment in the study
  Exclusion Criteria:
  -  other types of pancreatic cancer, in particular endocrine tumor or acinar cells
  -  ampulloma
  -  metastatic disease
  -  other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
  -  patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
  -  patient under guardianship, curator or under the protection of justice.

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 Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

Summary: Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC.
  Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.


Eligibility: Inclusion Criteria:
  -  Undergone curative surgery of gastric cancer,
  -  18-80 years old.
  Exclusion Criteria:

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

Clinical trial: Onco-geriatric Database of Patients With Pancreatic Cancer

Summary: This data base has been set in order to gather oncogeriatric information from elderly patients with pancreatic cancer who underwent an oncogeriatric evaluation.
  ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer Research Site).


Eligibility: Inclusion Criteria:
  -  Age>70 years
  -  Oncogeriatric evaluation done
  Exclusion Criteria:
  -  Patient refusal to participate in the study

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

Clinical trial: Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients

Summary: Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia.
  In a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.
  From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.


Eligibility: Inclusion Criteria:
  -  Patients with pathologically confirmed pancreatic adenocarcinoma
  -  Patients with radiologically identified metastasis (CT or MRI)
  -  Patients with no history of previous chemotherapy
  -  Patients with ECOG score 0-2
  Exclusion Criteria:
  -  Patients who have an experience of hyperthermia treatment
  -  Patients who have a difficulty of sensing heat
  -  Patients who have a skin graft or breast reconstruction surgery
  -  Patients who have a cardiac pacemaker or an implanted metal
  -  Pregnant or breast feeding women
  -  Patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
  -  Patients who were treated with unproved drugs within 30 days
  -  Patients who have a serious disease which can affect the person's safety
  -  Patients who do not consent to the study

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 Surgical Database

Summary: This data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.


Eligibility: Inclusion Criteria:
  -  Patient >18 ans
  -  Surgery for a pancreatic cancer
  Exclusion Criteria:
  -  Patient refusal to participate in the study

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 Cancer Registry: For Any Person With a Personal or Family History

Summary: The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the investigators are interested in both the genetic and non-genetic causes of pancreatic cancer. The investigators are particularly interested in finding the genes that cause pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another close relative who has also developed pancreatic cancer. This clustering of pancreatic cancers in families has yet to be explained; however, the investigators continue to identify new familial pancreatic cancer genes that explain this clustering in subsets of families. For example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in families.


Eligibility: Inclusion Criteria:
  -  personal or family history of pancreas tumors
  Exclusion Criteria:

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

Clinical trial: Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities

Summary: Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in the world. This is due to high recurrent rate after surgical resection and poor response to chemotherapy and radiotherapy.
  Recent studies revealed that peri-tumoral structure and patients' immune status including cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While past studies focused on oncogenes and tumor suppressor genes, recent studies focused on patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated to cancer progression and metastasis.
  Natural killer cells, playing an important role in cytotoxic immune system, are revealed to be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer progression and metastasis were accelerated.
  This study sought to find the correlation of patients' cytotoxic immune status to cancer progression and status by measurement of NK cell activity in pancreatic cancer patients. This would be basic support to construct a prognostic model of pancreatic cancer for early metastasis and post operational recurrence.


Eligibility: Inclusion Criteria:
  -  age over 18 and under 85
  -  Control group : incidental found benign pancreatic cyst, non-neoplastic gall bladder polyp (ex, cholesterol polyp), healthy people having no evidence of malignancy in check up within 1 year
  -  Patient group : histological diagnosed pancreatic cancer patients, clinically diagnosed pancreatic cancer patients by radiologic evaluation
  -  Agreed to enroll the study and signed informed consent
  Exclusion Criteria:
  -  Patients with other malignancies within 5 years
  -  Patients treated with steroid due to any reason within 1 year
  -  Not signed 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: Norwegian Pancreatic Cancer Trial (NorPACT) - 1

Summary: This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Detailed description: Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC).
  Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear.
  The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Eligibility: Inclusion Criteria:
  -  Resectable adenocarcinoma of the pancreatic head
  -  T1-3, Nx, M0 (UICC 7th version, 2010)
  -  Cytologic or histologic confirmation of adenocarcinoma
  -  Age > 18 year and considered fit for major surgery
  -  Written informed consent
  -  Considered able to receive the study specific chemotherapy
  Exclusion Criteria:
  -  Co-morbidity precluding pancreaticoduodenectomy
  -  Chronic neuropathy ≥ grade 2
  -  WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
  -  Platelet count < 100 000 per cubic millimeter
  -  Serum creatinine > 1.5 UNL (upper limit normal range)
  -  Albumin < 2,5 g/dl
  -  Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
  -  Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
  -  Percutaneous tumor biopsy
  -  Any reason why, in the opinion of the investigator, the patient should not participate
  -  Pregnancy
  -  Breastfeeding

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

Clinical trial: Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Summary: This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.
  Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Detailed description: This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.
  Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.
  Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Eligibility: Inclusion Criteria:
  -  Patients who will undergo pancreatoduodenectomy for periampullary tumors
  Exclusion Criteria:
  -  Patients with preoperative pancreatitis
  -  Patients who did not undergo pancreatoduodenectomy
  -  Patients who underwent bypass surgery or total pancreatectomy
  -  Patients who injection of octreotide less than 5 days

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 Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations

Summary: Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.

Detailed description: This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration & purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.

Eligibility: Inclusion Criteria:
  -  Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis
  Exclusion Criteria:
  -  <18 years old
  -  current pancreatitis (<72hrs before ERCP)
  -  pregnant woman, breast-feeding woman
  -  patient refusal
  -  contraindication of ERCP
  -  patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy
  -  chronic pancreatitis
  -  patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis)
  -  patients who have pancreatic or biliary malignancy

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

Clinical trial: Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer

Summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Detailed description: In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
  So in this study, we will collect ctDNA of pancreatic cancer patients who underwent operation, and will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

Eligibility: Inclusion Criteria:
  -  Pancreatic cancer patients who progress EUS-FNA for pancreatic cancer diagnosis
  -  Pancreatic cancer patients who are in operable stage.
  Exclusion Criteria:
  -  Foreigners
  -  Pancreatic cancer patients who have other cancer
  -  Patients who impossible to consent to study by own

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

Clinical trial: Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma

Summary: The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the follow-up.


Eligibility: Inclusion Criteria:
  -  All patients consecutive enrolled from January 2009 to December 2015 who underwent at least one chemotherapy for pancreatic adenocarcinoma, whatever the stage
  Exclusion Criteria:
  -  A patient record captured outside the time frame from January 2009 to December 2015

Relevance to patient case: not relevant