araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

Summary: Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.
  The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.


Eligibility: Inclusion Criteria:
  Night VOC Group:
  -  night VOC ≥ 2 in the previous year
  -  written informed consent
  Daytime VOC Group:
  -  VOC no nocturnal
  -  diurnal VOC ≥ 2 in the previous year
  -  written informed consent
  Slightly symptomatic group:
  -  no hospitalization for VOC
  -  written informed consent
  Exclusion Criteria:
  -  Taking opioids
  -  Taking medication that alters sleep (antidepressants, benzodiazepines ...)
  -  Known history of sleep apnea syndrome
  -  Known history of serious psychiatric disorder
  -  Recent vaso-occlusive crisis (within 3 weeks)
  -  Changes in background treatment (Hydrea or exchange transfusions) in the past 12 months

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer

Summary: The overall purpose of the study is to evaluate a method for offering mutation analysis of BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosis and family history. Information about the study as well as pre-test genetic counseling will primarily be given in a written way. In addition to that, if a study participant wishes to, she can also receive pre-test telephone genetic counseling.

Detailed description: Study population:
  All patients with newly diagnosed breast cancer in southern Sweden are offered inclusion in the SCAN-B study at the time of diagnosis pre-surgery. If they consent to that, a part of the tumor is sent to a lab in Lund, Sweden, for research purposes (RNA sequencing etc.). Patients that are included in the SCAN-B study are eligible for inclusion in BRCAsearch, see inclusion and exclusion criteria.
  Study procedure (summary):
  1. An envelope with written information is given to the patient at the visit to the surgeon the week after surgery. This envelope contains a written genetic counseling, information about the study, an informed consent form, psychosocial questionnaires and our contact information (telephone, e-mail). The patient can contact a genetic counselor for pre-test telephone genetic counseling if she wishes to.
  2. BRCA1 and BRCA2 are analyzed by full sequencing.
  3. Non-carriers are informed about the test result with a letter. Mutation carriers and VUS (variants of uncertain significance) are telephoned and given a time for an appointment at the Department of Clinical Genetics within a week.
  4. Psychosocial self-reported questionnaires (HAD scale, EORTC QLQ-C30, EORTC QLQ-BR23) are delivered at 3 times: At invitation to the study, one month after information about test result, and one year after information about test result.

Eligibility: Inclusion Criteria:
  1. The patient is included in the SCAN-B study.
  2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ.
  3. The patient has signed an informed consent form.
  Exclusion Criteria:
  1. The patient is unable to understand the written information in Swedish.
  2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: The Registration Program of BRCA1/2 Gene

Summary: Purpose:
  1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
  2. To build the breast cancer BRCA1/2 mutation database of Chinese group.
  3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

Detailed description: It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.

Eligibility: Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).
  The selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).
  Inclusion Criteria:
  Patients: it must be from independent family and meet the one or more of the following conditions.
  1. Patients' age at diagnosis: 45 years or younger.
  2. Patients' age at diagnosis: 50 years or younger.
  3. Breast cancer patients: it must meet the one or more of the following family medical histories.
  3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.
  3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.
  3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.
  3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.
  3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading＞7, any of age).
  3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.
  4. Triple negative patients' age of onset: 60 years or younger.
  5. Patients: male and have breast cancer.
  Patients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):
  First or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.
  First or second degree male relatives of patients have breast cancer.
  Exclusion Criteria:

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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