araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

Summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed cholangiocarcinoma
  -  Primary lesions (cholangiocarcinoma) are not resected
  -  Serum bilirubin level of 2.0 mg/dl or less.
  -  Performance status of 0 or 1.
  -  Expected survival of 1 year or more.
  -  Informed consent from the patient.
  Exclusion Criteria:
  -  With extrahepatic metastases
  -  With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: 90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Summary: The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).


Eligibility: Inclusion Criteria:
  -  Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon.
  -  No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.
  -  Only previous single agent chemotherapy for ICC allowed.
  -  Patient may have prior liver resection.
  -  Age > 18 years of age.
  -  Eastern Cooperative Oncology Group (ECOG) performance status < 2 (see Appendix E)
  -  Child's Pugh score of A (see Appendix F)
  -  Life expectancy of greater than 4 months
  -  Normal organ and marrow function as outlined in the protocol.
  -  Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for > 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
  -  Patients with well controlled HIV infection are eligible if their CD4 count is >499/cu mm and viral load is < 50 copies/ml.
  -  Pre-certification for the 90Y TARE should be performed prior to enrollment on this study.
  -  All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier.
  -  Patients may not be receiving any other investigational agents.
  -  Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria
  -  Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C
  -  Pregnant women are excluded from this study.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: 11C-Methionine PET as Prognostic Marker of Gliomas

Summary: This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.

Detailed description: This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center.
  We will review 11C-Methionine PET data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to IDH1 mutation status, MGMT promoter methylation and 1p/19q co-deletion. These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Eligibility: Inclusion Criteria:
  -  Diagnosis of glioma
  -  11C-Methionine within 30 days before surgery
  Exclusion Criteria:
  -  Absence of tumor specimen
  -  No clinical data
  -  11C-Methionine can not be evaluated

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Summary: The aim of this study is to compare the surgical outcomes of conventional lymph node dissection with unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Detailed description: Intrahepatic cholangiocarcinoma (ICC) is one of the primary liver cancer, which has higher malignant, more difficult treatment and worse prognosis compared to hepatocellular carcinoma and its incidence continues to rise. The main radical treatment is surgical resection, however, postoperative recurrence rate is extremely high. The 3-year recurrence rate is more than 50%. It is reported that lymph node metastasis rate of ICC is as high as 20% to 65%, which is the most significant factor of the poor prognosis. The probability of lymph node metastasis is 13% when lymph nodes metastasis were not found preoperative or intraoperative. It is highly controversial whether or not to undergo conventional lymph node dissection when lymph nodes metastasis were not found preoperative or intraoperative . A number of researchers approved of lymph node dissection at that situation. However, some authors such as Kim suggest that lymph node resection is not necessary. Others such as Yang think should consider in different condition. Clark CJ thinks that the evidence for dissection or not of lymph node is insufficient in view of the above reasons, the investigators have planned to implement a randomized controlled study to confirm the prognostic value of conventional or unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  -  Male or female patients > 18 years and <=70 years of age.
  -  Diagnosis of intrahepatic cholangiocarcinoma ( through imaging, serology, intraoperative frozen, etc.)
  -  No lymph node metastasis preoperatively or intraoperatively.
  -  Tumors can be completely resected.
  -  Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  -  Patients who can understand this trial and have signed information consent. Exclusion Criteria:Lymph node metastasis preoperatively.
  -  Tumors can not be resected .
  -  Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
  -  Patients with a medical history of other malignant tumors.
  -  Subjects participating in other clinical trials.
  -  liver function:Child C.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Summary: To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

Detailed description: chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Eligibility: Inclusion Criteria:
  -  ECOG PS≤1;
  -  pathologically confirmed adenocarcinoma of bile duct;
  -  R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size >5 cm, preoperative CA199>200 U/mL.
  -  postoperative liver function Child Pugh Class A, leukocyte count>1.5*10^9/L, platelet count>100*10^9/L, serum alanine aminotransferase <1.5*ULN
  -  no tumor recurrence or metastasis on baseline examination
  -  no history of radiotherapy or intervention therapy
  Exclusion Criteria:
  -  hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
  -  distant metastasis
  -  prothrombin time >14s
  -  severe cardiopulmonary dysfunction
  -  severe renal dysfunction
  -  bone marrow suppression before the initiation of therapy
  -  allergic to fluorouracil, gemcitabine, or platinum
  -  gemcitabine was used in combination with radiotherapy

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Endoscopic Biliary RFA of Malignant Bile Duct Obstruction

Summary: Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.

Detailed description: Malignant bile duct obstructions are caused by many diseases arising from primary or metastatic disease in intrahepatic, extrahepatic or hilar locations. To relieve obstructive decompression and jaundice as a result of the obstruction, endoscopic stent placement is usually required. Compared with surgical intervention, stent insertion offers shorter hospitalization, lower overall cost and lower morbidity. Previous studies have shown the superiority of SEMSs over plastic stents for maintaining biliary drainage. However, SEMS can occlude due to epithelial hyperplasia, tumor in-/overgrowth, biofilm deposition and sludge formation. Studies have showed that the median SEMS patency is 120 days. Once bile duct obstruction reoccurs, it may lead to significant morbidity and mortality. Thus, long-term patency of the SEMS remains an unresolved issue.
  Recently, endoscopic biliary radiofrequency ablation (RFA) have been used in patients suffering from inoperable malignant bile duct obstruction, and increasing the duration of stent patency. It delivers a high amount of thermal energy to target tissue with curative or palliative intent. The purpose of this study is to record information and evaluate the impact of radiofrequency ablation in improving the management of cholangiocarcinoma or malignant bile duct obstruction, and to compare the effects of SEMS plus RFA to SEMS alone.

Eligibility: Inclusion Criteria:
  1. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
  2. Inoperability by staging, comorbidities or patient wishes
  Exclusion Criteria:
  1. History of bleeding disorder or use of anticoagulation
  2. prior cardiac pacemaker placement
  3. Presence of serious dysfunction of heart, lung or kidney.
  4. Presence of other malignancy
  5. Pregnancy
  6. Prior SEMS placement
  7. Prior Billroth II or roux-en Y reconstruction

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

Summary: The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.

Detailed description: Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. It is often clinically silent with symptoms developing only in advanced disease. Surgical resection is the recommended curative intervention with only a minority of patients (10—20%) having potentially resectable tumors at time of diagnosis.
  Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival.
  Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. Several studies suggest PDT plus biliary stent placement may prolong survival (range of 360—630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. The aim of this study is to determine the effectiveness and safety of PDT with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable CCA in China.

Eligibility: Inclusion Criteria:
  -  Obtention of a written informed consent.
  -  Patient over 18.
  -  Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
  -  Patient with Karnofsky score ≥ 50 %
  -  Patient capable of fill in the quality of life questionnaire
  Exclusion Criteria:
  -  No written informed consent.
  -  Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
  -  Patients with porphyria or hypersensibility to porphyrins.
  -  Pregnant, parturient or breastfeeding women.
  -  Patient under 18.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Summary: The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection


Eligibility: Inclusion Criteria:
  -  Male or female patients > 18 years and <=70 years of age.
  -  Pathological evidence of ICC
  -  Tumors can be completely resected.
  -  Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  -  Patients who can understand this trial and have signed information consent.
  Exclusion Criteria:
  -  Tumors can not be resected .
  -  Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
  -  Patients with a medical history of other malignant tumors.
  -  Subjects participating in other clinical trials.
  -  Liver function:Child C.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Non Invasive Detection of IDH1/2 Mutation in Gliomas

Summary: This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.
  In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.
  In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.

Detailed description: The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
  The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
  The secondary endpoints include:
  1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
  2. Differentiation of tumor recurrence from radiation induced changes
  3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction

Eligibility: Inclusion criteria
  1. Affiliation to a social security system
  2. Patient≥ 18 years old
  3. Written informed consent
  4. One of the two situations:
  -  presumed grade II-III glioma candidate to surgery (group 1)
  -  IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
  5. Evaluable tumoral mass min diameter >2 cm (FLAIR)
  6. PKPS > 60
  Exclusion criteria
  1. Contra-indication to MRI
  2. Patient unable to give an written Informed Consent
  3. Patient under guardianship or deprived of freedom
  4. For group 2: patient already included in group 1

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors

Summary: Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.


Eligibility: Inclusion Criteria:
  1. Patient (male/female) ≥ 18 years of age
  2. Written informed consent obtained prior to any trial specific procedure
  3. Patient suffering from gastrointestinal tumors: Cholangiocarcinoma (CC), Pancreatic ductal adenocarcinoma (PDAC), Colorectal Cancer (CRC), Gastric Cancer (GC)/ Adenocarcinoma of the Esophagogastreal Junction (AEG) / Esophagus cancer (EC).
  4. Planned to receive palliative chemotherapy
  5. No prior palliative chemotherapy
  6. ECOG performance status of 0 or 1
  7. Life expectancy of 12 weeks or more
  8. Adequate hematological parameters, as demonstrated by:
  -  Hemoglobin > 9.0 g/dl (5.6 mmol/l)
  -  WBC ≥ 3.0 x 109/l
  -  ANC ≥ 1500/mm³
  -  Platelets ≥ 75 x 109/l
  -  S-creatinine ≤ 1.5 mg/dl (132 µmol/l)
  Exclusion Criteria:
  1. Underweight (BMI < 18.5)
  2. Dysphagia
  3. Insulin-dependent diabetes mellitus
  4. Renal failure requiring hemo- or peritoneal dialysis
  5. Pregnant or breast-feeding women
  6. Drug/alcohol abuse

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors

Summary: Multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.

Detailed description: Patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. Information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. A two-step data analysis will be performed: Task-1 analysis will define the risk factors landscape, Task-2 analysis will examine the influence of etiology on clinical outcomes. Anonymized data will be stored in a central database, kept at the Leading Centre.

Eligibility: Inclusion Criteria:
  -  voluntary, written, dated and signed informed consent;
  -  age ≥ 18 years;
  -  histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.
  Exclusion Criteria:
  -  Dementia or altered mental status leading to inability to understand or render the informed consent.
  -  Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation

Summary: Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.

Detailed description: Aims are to measure Macrophage Migration Inhibitory Factor in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.

Eligibility: Inclusion Criteria:
  -  End stage liver disease, chronic liver failure, orthotopic liver transplantation
  Exclusion Criteria:
  -  Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure

Relevance to patient case: not relevant