araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan

Summary: Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic head malignant tumours and to predict the resectability based on the preoperative imaging. To achieve this, a retrospective review of the preoperative CT scans will be conducted for all patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.

Detailed description: Pancreatic cancer arises from the glandular part of the pancreas and is the fifth most common cause for cancer related death in the UK. It. Ampullary carcinoma arises from the epithelium of the ampulla of Vater into which the common bile duct and pancreatic duct drain. Cholangiocarcinoma arises from the bile duct epithelium, and may occur within the intra-pancreatic portion of the distal common bile duct mimicking a pancreatic malignancy. Cancers arising from these origins often cause obstructive jaundice and are hard to distinguish. Surgery is indicated for the treatment of these types of malignant tumours, and the definitive final diagnosis is usually not known until the specimen is examined. This situation does not allow specific treatment to be given pre-operatively, so-called 'neo-adjuvant therapy'. The rationale for this approach is that in a proportion of patients the tumour will be made smaller by this treatment, which may facilitate surgical resection.

Eligibility: Inclusion Criteria:
  -  All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

Summary: This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.

Detailed description: This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.

Eligibility: Inclusion Criteria:
  -  A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
  -  The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
  -  The age of the patient is between 18 years old and 70 years old.
  -  The condition of the patient permits the procedure of chemotherapy using PCV schema.
  -  The patient is informed consent, and willing to join in this research.
  Exclusion Criteria:
  -  The diagnosis is not recurrent high-grade glioma.
  -  The diagnosis of high-grade glioma was not established by pathological method.
  -  No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
  -  The age of the patient does not meet the requirement of this research.
  -  The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
  -  There are other conditions that the clinicians believe that the PCV chemotherapy is not appropriate for the patient.
  -  The patient is not willing to join in this research.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Summary: A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.


Eligibility: Inclusion Criteria:
  -  Documented IDH1R132-mutant tumors
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
  -  Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
  -  Acute Promyelocytic Leukemia
  -  Women who are pregnant or lactating
  Other protocol-defined Inclusion/Exclusion may apply

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

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: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

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: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Summary: The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

Detailed description: This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.

Eligibility: Inclusion Criteria:
  -  Male or female at least 9 years of age and older
  -  Written and verbal informed consent must be obtained.
  -  Subject must have a score moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
  -  Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
  -  Subjects must be willing to comply with study instructions and return to the clinic for required visits.
  Exclusion Criteria:
  -  Any dermatological conditions on the face that could interfere with clinical evaluations
  -  Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
  -  Subjects with a facial beard or mustache that could interfere with the study assessments
  -  Concomitant use of potentially irritating over-the-counter products

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

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: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

Summary: Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.

Detailed description: Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.
  Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.
  The aim of this study is to conduct a randomised, controlled, clinical trial to compare the effect of S-1 plus RFA with stent with RFA with stent in patients with unresectable cholangiocarcinoma.

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: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

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: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Summary: The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Detailed description: Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.
  Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.
  The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Eligibility: Inclusion Criteria:
  1. Malignant hilar biliary obstruction;
  2. Unresectable cases
  Exclusion Criteria:
  1. Bismuth I patients;
  2. inability to obtain informed consent;
  3. Eastern Cooperative Oncology Group performance status of 4;
  4. severe dysfunction in other organs.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

Summary: The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.

Detailed description: Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often develop resistance to treatment within months or weeks after salvage therapy. There are still no effective markers to predict the response rate to bevacizumab.
  So the investigators initiate a single-arm Phase II study to evaluate the efficacy and tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in patients with recurrent high-grade glioma.

Eligibility: Inclusion Criteria:
  -  Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
  -  All patients should complete radiotherapy and chemotherapy for primary gliomas
  -  Enhanced MRI and magnetic resonance spectroscopy showed unequivocal evidence of tumor recurrence or progression.
  -  Those patients underwent surgical resection after tumor recurrence can also be enrolled if histological diagnosis of GBM is available, and MRI within 3 days after operation is needed.
  -  The patients with recurrent gliomas didn't undergo bevacizumab therapy before enrollment.
  -  The time to be enrolled should be more than 90 days after the radiation therapy, more than 28 days after operation for recurrent tumor or prior chemotherapy.
  -  Eastern Cooperative Oncology Group score: 0-2
  -  Written informed consent
  -  Laboratory test: Neutrophil count > 1.5*10^9/L, platelet count > 100*109/L, hemoglobin > 8 g/dL, blood urea nitrogen and creatinine < 1.5 upper limit of normal(ULN), blood total bilirubin and conjugated bilirubin < 1.5 ULN, alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 3 ULN, alkaline phosphatase(AKP) < 2 ULN
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Allergic to administered drugs
  -  Radiation therapy in the previous 90 days before enrollment
  -  The patients with recurrent gliomas were treated with bevacizumab therapy before enrollment.
  -  Acute infection in need of antibiotics intravenously
  -  Participation in other clinical trials in the 90 days before enrollment

Relevance to patient case: not relevant