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: Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Summary: Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Detailed description: The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
  The inclusion criteria included:
  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.

Eligibility: Inclusion Criteria:
  1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  Exclusion Criteria:
  1. Patients receiving other anti-cancer drugs;
  2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
  3. Patient with inadequate Blood system,liver function and renal function.
  4. Brain metastasis is of symptoms
  5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
  6. Chronic enteritis or intestinal obstruction
  7. Bone marrow failure
  8. Mental disease difficult to control
  9. Participated other clinic trial within 3 months
  10. Pregnant or lactation patients
  11. The researcher evaluate the patient is not suitable for this trial.

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: EUS Guided Celiac Neurolysis

Summary: -  Hypothesis:
  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
  -  Rationale:
  -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility: Inclusion Criteria:
  -  1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  -  2. Cytologic or histologic confirmation of pancreatic carcinoma
  -  3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  -  4. EUS clinically indicated (for non-study purposes)
  Exclusion Criteria:
  -  1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  -  2. Abdominal surgery within 1 month
  -  3. Prior celiac plexus or ganglia neurolysis.
  -  4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  -  5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

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: Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery

Summary: This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology

Detailed description: PRIMARY OBJECTIVES:
  I. To compare margin status on final pathology with margin status from cytopathologic evaluation.
  OUTLINE:
  Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.

Eligibility: Inclusion Criteria:
  -  patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
  -  ages 18 years to 80 years old
  Exclusion Criteria:
  -  Pregnant women

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: Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras

Summary: The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.


Eligibility: Inclusion Criteria:
  -  Histologic diagnosis colorectal carcinoma
  -  Metastatic disease
  -  Signed informed consent
  Exclusion Criteria:
  -  Prior treatment of metastatic colorectal cancer
  -  Refusal or incapability of providing informed consent

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: Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

Summary: The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours
  The specific sub-objectives of the studies are:
  -  To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method.
  -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
  -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy.
  -  To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
  -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.

Detailed description: The primary outcome is monitor for toxicity effect for the combination therapy.

Eligibility: Inclusion Criteria:
  -  Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate
  Exclusion Criteria:
  -  Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
  -  Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
  -  Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
  -  Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
  -  Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
  -  Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
  -  Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
  -  Patient is pregnant or is breast-feeding.
  -  Patient is allergic to or intolerant of gemcitabine
  -  Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
  -  Any reason why, in the opinion of the investigator, the patient should not participate.

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: 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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