araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

Summary: This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.

Detailed description: The study is being done in 2 parts. The first part is the dose escalation part where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.
  After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
  2. Have measurable disease.
  3. Male or non-pregnant and non-lactating female of age >18 years.
  4. ECOG performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
  5. Subjects must have adequate organ and marrow function.
  6. Must use acceptable form of birth control prior to study and and for the duration of study.
  7. Willing and able to comply with study procedures
  Exclusion Criteria:
  1. Patient who have had any prior chemotherapy within 5 years of enrollment.
  2. Patient who have had radiotherapy for pancreatic cancer.
  3. Age ≥ 76 years
  4. Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
  5. Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
  6. Patient who has known brain metastases.
  7. Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan.
  8. Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  9. Patient who has serious medical risk factors involving any of the major organ systems.
  10. Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
  11. Pregnant or breast feeding.
  12. Patient is unwilling or unable to comply with study procedures
  13. Patient with clinically significant wound

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: CTC Pancreatic Adenocarcinoma

Summary: Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)

Detailed description: This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.

Eligibility: Inclusion Criteria:
  -  Age 18 to 85
  -  ASA I-III ( American Society of Anesthesiologists)
  -  Resectable pancreatic adenocarcinoma
  -  Primary surgery
  -  No neoadjuvant therapy
  -  Written informed consent
  Exclusion Criteria:
  -  Metastatic disease
  -  Other than primary surgery (recurrence, reconstruction)
  -  Pre-operative chemotherapy
  -  Chronic opioid use
  -  Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
  -  Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
  -  Pregnancy
  -  Breast feeding
  -  Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

Summary: This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
  -  Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
  -  Anticipated life expectancy ≥ 12 weeks
  -  Radiographically measurable disease acc. to RECIST 1.1
  -  Use of adequate contraception (as described in protocol)
  -  Ability to provide written informed consent and comply with study requirements
  Exclusion Criteria:
  -  Received other cancer treatment or investigational drug within 4 weeks prior to screening
  -  Women who are pregnant or breastfeeding
  -  Had major surgery within 4 weeks of first dose of study drug
  -  Inadequate liver, renal or bone marrow function within 2 weeks of first dose
  -  Serious concurrent illness, altered medical status or any uncontrolled medical condition
  -  Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
  -  Known active HIV, HBV or HCV infection
  -  Inability to swallow tablets
  -  History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)

Summary: Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.


Eligibility: Inclusion Criteria:
  1. Healthy adults between 18 and 65 years old
  2. Subject understands the study protocol and agrees to comply with it
  3. Informed Consent Form signed by the subject
  Exclusion Criteria:
  1. Subjects using vitamin supplements containing vitamin k
  2. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
  3. Subjects presenting chronic degenerative and/or inflammatory diseases
  4. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  5. Subjects receiving corticosteroid treatment
  6. Subjects using oral anticoagulants
  7. Subjects with a history of soy allergy
  8. Subjects who have participated in a clinical study more recently than one month before the current study

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Summary: The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.


Eligibility: Inclusion Criteria:
  -  Surgeon trained in and performing the HIPEC procedure
  Exclusion Criteria:
  -  Not performing the HIPEC procedure

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Summary: This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  -  Stage IV disease diagnosed within 6 weeks of randomization
  -  Adequate hematologic function:
  -  Absolute neutrophil count (ANC) ≥1.5 x 109/L
  -  Platelet count ≥100 x 109/L
  -  Hemoglobin ≥9 g/dL
  -  Adequate hepatic and renal function defined as:
  -  AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  -  Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
  -  Estimated Creatinine Clearance ≥30 mL/min
  -  KPS ≥70.
  -  Eastern Cooperative Oncology Group (ECOG) 0-1
  Exclusion Criteria:
  -  Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
  -  Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
  -  Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
  -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  -  Major surgery within 4 weeks of first dose of study drug.
  -  Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: According CTC to Compare the Influences of Different Methods to Remove the PDAC

Summary: Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.


Eligibility: Inclusion Criteria:
  -  Ductal adenocarcinoma of pancreatic body and tail
  -  Tumor can be removed
  -  No other tumors and without liver metastases
  -  Age from 18 to 80 years old
  Exclusion Criteria:
  -  Neoplasms with other sites of the pancreas
  -  With other tumors of any other sites

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI

Summary: The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.


Eligibility: Inclusion Criteria:
  -  BRCA 1 or 2 mutation
  -  Age ≥ 30
  -  Patients scheduled to undergo screening breast MRI with contrast
  Exclusion Criteria:
  -  Patients with known breast cancer
  -  Patients unable to complete their scheduled breast MRI
  -  Patients with prior pancreatic surgery or cancers
  -  Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
  -  Patients with prior abdominal or pelvic surgery

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Summary: This is an open-label, phase 2 comparative study to assess the safety, tolerability, and efficacy of nal-IRI in combination with other anticancer therapies, compared to nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy. This study will assess the following regimens:
  -  nal-IRI + 5-FU/LV + oxaliplatin
  -  nal-IRI + 5-FU/LV
  -  nab-paclitaxel + gemcitabine
  The study will be conducted in two parts:
  1. a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and
  2. a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV, versus nab-paclitaxel + gemcitabine.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed adenocarcinoma of the pancreas not previously treated in the metastatic setting
  Part 1: Unresectable, locally advanced or metastatic disease; diagnosed within 6 wks prior to enrollment; Part 2: Metastatic disease; diagnosed within 6 wks prior to randomization
  -  Measurable or non-measurable disease as defined by RECIST v1.1
  -  ECOG performance of 0 or 1
  -  Adequate hematological, hepatic, renal and cardiac function
  Exclusion Criteria:
  -  Prior treatment of pancreatic cancer in the metastatic setting with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
  -  Prior treatment of pancreatic cancer with chemotherapy (radiation sensitizer allowed if ≥ 6 months has elapsed from completion)
  -  Uncontrolled CNS metastases
  -  Clinically significant gastrointestinal disorder
  -  History of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible
  -  Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin, oxaliplatin, nab-paclitaxel (part 2 only) or gemcitabine (part 2 only)
  -  Use of strong CYP3A4 or CYP2C8 inhibitors or inducers (part 2 only)
  -  Pregnant or breast feeding

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III

Summary: After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.
  The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Male or female, age superior to 18 years.
  -  Histologically confirmed colonic or rectal adenocarcinoma.
  -  stage II or III (TNM classification).
  -  Curative resection (R0)
  -  Absence of metastasis (abdominal ultrasonography or CTscan and pulmonary Rx or CTscan) in exams performed within 4 weeks.
  -  ECOG performance status <3.
  -  Signed and dated informed consent document.
  Exclusion Criteria:
  -  Metastatic disease.
  -  Familial adenomatous polyposis
  -  Prior chemotherapy and or radiotherapy within 6 weeks
  -  Medical history of cancer within 5 years except: basocellular cutaneous neoplasia and intraepithelial neoplasia of the cervix

Relevance to patient case: definitely relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

Summary: Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Detailed description: Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

Eligibility: Inclusion Criteria:
  Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)
  Exclusion Criteria:
  Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

Summary: This phase I/II trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging and to see how well they work in finding pancreatic cancer in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a special imaging device.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the efficacy of cetuximab IRDye800 (cetuximab-IRDye 800CW) in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.
  SECONDARY OBJECTIVES:
  I. To determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.
  OUTLINE: This is a dose-escalation study.
  Patients receive cetuximab-IRDye 800CW intravenously (IV) over 30 minutes to 1 hour on day 0. Within 2-5 days, patients undergo surgery with intraoperative imaging.
  After completion of study treatment, patients are followed up at days 10 and 30.

Eligibility: Inclusion Criteria:
  -  Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
  -  Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
  -  Life expectancy of more than 12 weeks
  -  Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
  -  Hemoglobin >= 9 gm/dL
  -  Platelet count >= 100,000/mm^3
  -  Magnesium, potassium and calcium > the lower limit of normal per institution normal lab values
  -  Thyroid-stimulating hormone (TSH) < 13 micro International units/mL
  Exclusion Criteria:
  -  Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
  -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
  -  History of infusion reactions to cetuximab or other monoclonal antibody therapies
  -  Pregnant or breastfeeding
  -  Patients who have a serious reaction with the test/loading cetuximab dose for which they were not able to receive the full dose
  -  Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
  -  Lab values that in the opinion of the primary surgeon would prevent surgical resection
  -  Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Relevance to patient case: not relevant