araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Summary: In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.


Eligibility: Inclusion Criteria:
  -  Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
  -  Previously treatment with gemcitabine as adjuvant or metastatic disease.
  -  Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
  -  Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  -  At least 10 weeks of life expectation.
  -  Adequate organ function defined as:
  -  Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
  -  Total Bilirubin ≤ 2,0 x ULN
  -  Absolute neutrophil count ≥ 1,500/ mm3
  -  Platelets ≥100.000/ mm3
  -  Hemoglobin ≥ 8,0 g/dl
  -  Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
  -  Signed written informed consent.
  Exclusion Criteria:
  -  Major surgical procedure within 4 weeks of the beginning of the treatment.
  -  History of serious clinical or psychiatric disease.
  -  Symptomatic hypoglycemia at the screening visit.
  -  Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
  -  Treatment with any anti-cancer investigational drug.
  -  Treatment with any IGF-I or IGFR-I
  -  Treatment with metformin within 12 months prior to commencing study treatment
  -  For female patients, current pregnancy and/or lactation

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: PAncreatic Adenocarcinoma in Hospital

Summary: Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.
  Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life.
  The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country.
  The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.


Eligibility: Inclusion Criteria:
  -  Living in France
  -  Pancreatic adenocarcinoma histologically or cytologically proven
  -  primary diagnosis
  -  Agreed to participate
  Exclusion Criteria:
  -  Suspected pancreatic adenocarcinoma histologically or cytologically unproven
  -  Refused to participate

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Summary: Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.


Eligibility: Pancreatic cancer Group
  Inclusion Criteria:
  -  Age from 18 years old
  -  Pancreatic cancer positive biopsy
  -  Before any treatment
  -  Signed Informed Patient Consent
  Exclusion Criteria:
  -  Age under 18 years old
  -  Neoadjovant treatment
  -  Post surgery for Pancreatic cancer
  -  A history of any other cancer type, except skin cancer that is not melanoma
  Healthy Group
  Inclusion Criteria:
  -  Healthy patients
  -  No history of Pancreatic cancer
  -  Signed Informed Patient Consent
  Exclusion Criteria:
  -  History of Pancreatic cancer
  -  Pancreatic cancer background in the family
  -  A history of any other cancer type, except skin cancer that is not melanoma

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

Summary: Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma


Eligibility: Inclusion Criteria:
  -  Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease
  -  2nd line, 3rd line or greater
  -  At least 18 years of age
  -  ECOG of 0 or 1
  -  Anticipated life expectancy >12 weeks
  -  For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
  -  Have adequate organ function as defined by specified laboratory values
  Exclusion Criteria:
  -  Allergy to both penicillin & sulfa or suspected hypersensitivity to GM-CSF, dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options
  -  Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
  -  Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
  -  Have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed
  -  Rapidly progressing disease
  -  Clinically significant and/or malignant pleural effusion
  -  Received prior GVAX pancreas vaccine or CRS-207
  -  Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
  -  Infection with HIV or hepatitis B or C at screening
  -  Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
  -  Be pregnant or breastfeeding
  -  Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
  -  Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer

Summary: Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
  -  ECOG Performance Status of 0 to 1.
  -  Adequate organ function as defined by study-specified laboratory tests.
  -  Signed informed consent form.
  -  Willing and able to comply with study procedures.
  Exclusion Criteria:
  -  Previous chemotherapy or target therapy.
  -  Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
  -  Systemically active steroids.
  -  Another investigational product within 28 days prior to receiving study drug.
  -  Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
  -  Infection with HIV, hepatitis B or C at screening.
  -  Pregnant or lactating.
  -  Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)

Summary: The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.


Eligibility: Inclusion Criteria:
  A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:
  1. 18 years of age or older.
  2. Suspected RCC, in the opinion of the investigator
  3. Availability of either:
  -  Nephrectomy or other surgically removed tissue (Stage I); or,
  -  Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
  4. ≥5 biopsy specimens available from BRPC.
  -  Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
  5. Not currently being treated with systemic therapy.
  Exclusion Criteria:
  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.
  Expansion Cohort for Genitourinary Cancers:
  Inclusion Criteria:
  1. 18 years of age or older
  2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
  3. Availability of surgically removed tissue or biopsy tissue.
  4. At least 2 biopsy specimens available from BRPC
  5. Not currently being treated with systemic therapy.
  Exclusion Criteria:
  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

Summary: This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Detailed description: Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Eligibility: Inclusion Criteria:
  -  Patients have provided a signed Informed Consent Form
  -  ECOG performance status of 0-1
  -  BMI ≥ 18.5
  -  Age: 18-65 years old
  -  Histologically confirmed diagnosis of metastatic pancreatic cancer
  -  No prior palliative chemotherapy
  -  Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
  -  Life expectancy ≥ 3 months
  -  Patient has adequate bone marrow and organ function
  -  Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
  -  Platelets ≥ 90 x 109/L
  -  Hemoglobin ≥ 90 g/L
  -  Patient has adequate liver function
  -  AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  -  Serum bilirubin ≤ 1.2 x ULN
  -  Creatinine ≤ 1.25 times ULN
  -  Good compliance
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Brain metastasis or only with bone metastasis.
  -  Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
  -  Refuse to take appropriate contraceptive measures (including male patients).
  -  Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
  -  Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
  -  Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
  -  Psychiatric illness that would prevent the patient from giving informed consent.
  -  Patient is concurrently using other antineoplastic agent
  -  Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
  -  Known HIV-positivity.
  -  No history of chronic diarrhea, nausea or vomit.
  -  No ≥ grade 2 sensory peripheral neuropathy.
  -  A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
  -  Infectious disease or inflammation with body temperature ≥ 38 ℃.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

Summary: Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.
  Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Detailed description: Study population: Locally advanced unresectable pancreatic cancer patients
  Elegibility criteria:
  -  Written informed consent
  -  Age >18 < 75 years
  -  Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  -  At least one lesion measurable with CT or MRI scan
  -  Performance Status (ECOG) 0-1 at study entry
  -  Life expectancy of at least 3 months
  -  Adequate marrow, liver and renal function
  -  Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Age >18 < 75 years
  -  Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  -  At least one lesion measurable with CT or MRI scan
  -  Performance Status (ECOG) 0-1 at study entry
  -  Life expectancy of at least 3 months
  -  Adequate marrow, liver and renal function
  -  Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy for pancreatic cancer
  -  Severe cardiovascular disease
  -  Thrombotic or embolic events
  -  Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  -  Known hypersensitivity to study drug
  -  Known drugs or alcohol abuse
  -  Pregnant or breastfeeding women
  -  Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
  -  Unable to sign informed consent

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Summary: Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not available in literature.
  Although it is well known that pain is the main symptom of chronic pancreatitis, it has until now been assessed in very common and varying categories. Pain, however, is only one aspect of the large variety of sensitive facets of daily life. In addition to an improvement in pain symptoms and the preservation of pancreatic exocrine and endocrine function and other parameters, occupational rehabilitation of these mostly young patients and quality of life also should be considered in the evaluation of surgical outcome in alcoholic and non-alcoholic chronic pancreatitis.
  In this prospective study, we intend to find out if there are any differences in the surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic pancreatitis.We also plan to see if there are differences in the histopathology in these two disease settings.


Eligibility: Inclusion Criteria:
  Diagnosis of chronic pancreatitis confirmed by at least 2 of the following:
  1. Typical Chronic epigastric abdominal pain
  2. Elevation of serum Amylase>3 times upper limit normal or
  3. Fecal elastase less than 200ug/g stool.
  4. Confirmatory findings on cross-sectional imaging:
  1. Changes in size, shape and contour of pancreas
  2. Dilatation of main pancreatic duct
  3. Calcification
  4. Pseudocyst
  5. Pancreatic duct stricture
  5. Patients who fulfill the criteria for surgical intervention
  Exclusion Criteria:
  -  Not agreeing for surgical management
  -  On going acute pancreatitis
  -  Postop alcohol intake
  -  Pregnancy.
  -  Chronic pancreatitis with Malignancy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: DCE MRI in Diagnosing Patients With Pancreatic Cancer

Summary: This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field and radio frequency pulses. These pictures may help identify underlying malignancy in patients at high risk or active malignancy in patients who have undergone chemotherapy for pancreatic cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
  II. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
  III. Assess the ability to DCE MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
  SECONDARY OBJECTIVES:
  I. In each of the three groups listed above clinical factors associated with the presence of pancreatic cancer will be analyzed; in addition, disease free survival and overall survival will be analyzed in each group.
  OUTLINE: Patients are assigned to 1 of 3 groups.
  ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI for up to 3 scans.
  ARM II (Intraductal Papillary Mucinous Neoplasms (IPMN)): Patients undergo DCE MRI prior to surgery.
  ARM III (Unresectable pancreatic cancer): Patients undergo DCE MRI before and after neoadjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
  -  Must not have contraindication for MRI or intravenous (IV) contrast administration
  Exclusion Criteria:
  -  Allergy to intravenous contrast agents Prohance or Ferumoxytol

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Tumor Registry Pancreatic Cancer

Summary: The registry aims to collect and analyse information on the antineoplastic treatment of metastatic or locally advanced pancreatic cancer in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.


Eligibility: Inclusion Criteria:
  -  Metastatic or locally advanced pancreatic cancer
  -  18 years and older
  -  Antineoplastic treatment
  -  Date of consent no later than 2 weeks after start of first-line treatment
  Exclusion Criteria:
  -  No pancreatic cancer
  -  Below 18 years and older
  -  No antineoplastic treatment
  -  Date of consent later than 2 weeks after start of first-line treatment

Relevance to patient case: not relevant