araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed description: Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective pancreaticoduodenectomy
  -  Pancreatic gland with high risk criteria for associated postoperative morbidity
  Exclusion Criteria:
  -  Patients do not accept participation
  -  Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Pancreatic Juice Diagnosis From Duodenum

Summary: Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Detailed description: Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient.
  The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.

Eligibility: Inclusion Criteria:
  -  Common inclusion criterion
  -  Age is 18 years or older.
  -  Informed consent was obtained.
  -  Inclusion criterion for normal cohort
  -  An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  -  No findings of pancreatic disorder as documented by CT or MRI or EUS
  -  Inclusion criterion for PC suspicious cohort
  -  A EUS or ERCP is scheduled to suspected pancreatic disorder.
  Exclusion Criteria:
  -  Common exclusion criterion
  -  Severe cardiac disease
  -  Severe respiratory disease
  -  Bleeding disorders
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Role of Perfusion CT in Pancreatic Cancer

Summary: The purpose of this study is
  1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
  2. to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).

Detailed description: 1. Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
  2. Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma

Eligibility: Inclusion Criteria:
  -  patients who are older than eighteen years
  -  patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
  -  patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
  -  patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
  -  patients who agree with the study and whose informed consent is obtained.
  Exclusion Criteria:
  -  patients who are younger than eighteen years old
  -  patients in whom previously radiation therapy was performed and the RTx field includes pancreas
  -  patients with recurred pancreas adenocarcinoma
  -  patient who are pregnant or nursing patients
  -  patients with renal failure (GFR<30mL/min)
  -  patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
  -  patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
  -  Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

Summary: This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.


Eligibility: Inclusion Criteria:
  -  Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
  -  Please note, TP53 carrier cohort is complete and no longer open to recruitment
  -  Age between 18 and 60
  -  Able to give informed consent
  Exclusion Criteria:
  -  Individual with low penetrance TP53 mutation
  -  Individual with TP53 variant of unknown significance.
  -  Previous malignancy diagnosed < 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
  -  Current symptoms suggestive of malignancy
  -  Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
  -  Claustrophobia
  -  ECOG performance status >2

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

Summary: The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
  The experimental part of the study is combining these drugs together in FOLFOX-A.

Detailed description: More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed pancreatic ductal adenocarcinoma.
  -  Metastatic or locally advanced disease.
  -  No prior treatment for pancreatic cancer
  -  Radiographically measurable disease.
  -  No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
  -  Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  -  Preexisting neuropathy > grade 1.
  -  No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  -  ECOG performance status 0 or 1.
  -  Age ≥ 18 years of age.
  -  Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
  -  Required Initial Laboratory Values:
  -  Neutrophils ≥ 1,500/μl
  -  Platelet count ≥ 100,000/μl
  -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
  -  Total bilirubin ≤ 1.5 x ULN
  -  AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN
  Exclusion Criteria:
  -Patients with known brain metastases

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors

Summary: This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

Detailed description: This is a multi-center, open-label, dose finding, phase I study of single agent CGM097, administered in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. Patients' tumors must be characterized by p53wt status.
  The study consists of a dose escalation part, where cohorts of three to six newly enrolled patients will receive escalating doses of CGM097, and a dose expansion part, in which patients are given CGM097 the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Novartis and the site investigators will jointly decide on each dose escalation step based on the recommendation from an adaptive Bayesian logistic regression model (BLRM). If safety data should indicate a lower increment than suggested by the BLRM, the next dose level (DL) will be adjusted accordingly.

Eligibility: Inclusion Criteria:
  -  Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
  -  Tumor of the patient is p53wt
  -  Evaluable disease as determined by RECIST 1.1
  -  WHO performance status 0-2
  Exclusion criteria:
  -  Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor
  -  Patient with symptomatic or growing CNS metastatic lesions
  -  Concurrent other malignancy
  -  Clinically significant cardiac disease as defined in the protocol
  -  Diagnosis of acute or chronic pancreatitis
  -  Concomitant therapy that precludes enrollment, as defined in the protocol
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
  -  Pregnant or nursing women
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

Summary: The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Detailed description: Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.

Eligibility: Inclusion Criteria:
  1. Patients 18 years old or older
  2. Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.
  3. Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
  4. Patients who have signed the consent form for this study
  Exclusion Criteria:
  1. Pregnant or breast-feeding women.
  2. Patients with severely decreased renal function19-21.
  3. Patients with known severe allergic reactions to contrast.
  4. Patients who have difficulty lying flat on their back for extended periods of time.
  5. Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Summary: The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

Detailed description: No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Karnofsky Performance Status greater than or equal to 70%
  -  confirmed pancreatic or periampullary adenocarcinoma
  -  pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
  -  Either:
  -  standard of care treatment for pancreatic cancer that included radiation therapy
  * patients may be receiving continued chemotherapy post initial CRT. or
  -  standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
  -  acceptable organ and marrow function as determined by blood tests
  -  ability to understand and give consent
  -  must be a patient to be treated with SBRT only at Johns Hopkins Hospital
  -  life expectancy of greater than 3 months
  Exclusion Criteria:
  -  extensive metastatic disease
  -  performance status of less than 70
  -  children are excluded form the study
  -  no uncontrolled intercurrent illness
  -  no concurrent malignancy other than melanoma
  -  pregnant or breast feeding women are excluded
  -  women who are not post-menopausal and have a positive pregnancy test
  -  life expectancy of less than 3 months

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
  About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
  The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
  Exclusion Criteria:
  -  Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
  -  Pancreatic cancer with distant metastasis
  -  Unwilling to sign informed consent

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

Summary: Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Detailed description: The objective of this study are to determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens. The secondary objectives are 1) to assess the toxicity of each of these regimens in this setting. 2) To perform exploratory genomic analyses as a means of assessing molecular characteristics potentially associated with risk of relapse with one or both of the regimens. 3) To determine the relationship between known mutations and metabolic activity as measured by FDG-PET and risk of relapse.

Eligibility: Inclusion Criteria:
  -  Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
  -  Patients must have had all gross disease resected (R0 or R1 resection).
  -  Patients who underwent an R2 resection are not eligible.
  -  Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
  -  Age > 18 years.
  -  Patient must have ECOG performance status of 0-2.
  -  Patients must have normal organ and marrow function measured within 2 weeks. prior to registration as follows:
  ANC > 1,500/µL Platelets > 100,000/µL Total bilirubim less than 2-fold ULN AST(SGOT)/ALT(SGPT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.
  -  Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
  -  Women of childbearing potential and sexually active males are stronglt advised to use appropriate contraceptive measures.
  Women must not be pregnant or breast-feeding. All agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
  -  Patients must not be receiving any other investigational agents.
  -  Patients with known metastases are not eligible.
  -  Patients with wounds that have not fully healed are not eligible.
  Exclusion Criteria:

Relevance to patient case: not relevant