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

Clinical trial: Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
  -  Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
  -  Develop prognostic indicators for disease-specific and overall survival.
  -  Define new potential molecular targets for therapy.
  OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage non-small cell lung cancer
  -  T1 or T2, N0 disease
  -  Had a lobectomy or greater resection with negative surgical margins (R0 resection)
  -  Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials
  -  Node-negative with recurrent disease within 3 years (cases)
  -  Node-negative patients without recurrent disease (controls)
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009

Summary: -  There is no data at present concerning the KRAS mutation in patients from Martinique with colorectal cancer. Despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. This study has a descriptive purpose, allowing a comparison of the population from Martinique to other populations.
  -  A study of incidence of colorectal cancer, overseen by the Association from Martinique for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of the local characteristics of the colorectal cancer.
  -  These two descriptive characteristics of colorectal cancer in Martinique will be useful data for the health professionals to provide their patients better care.

Detailed description: -  The colorectal carcinogenesis is complex. It influences among others, the EGFR (Epidermal Growth Factor Receptor) which activation leads to tumoral proliferation, differentiation and invasion. The binding of the EGF (Epidermal Growth Factor) or of another ligand to the EGFR is responsible for the activation of the Ras- Raf and Pi3k pathways.
  -  The mutation of the genes KRAS, BRAF or PIK3CA results in their continuous activation, independently of the activation or of the pharmacological blocking of EGFR. The most frequently found mutation affects the KRAS gene (20 to 50 % of the cases). 90 % of these mutations are situated on codons 12 and 13 of this gene (70 % codon 12 and 30 % codon 13). These mutations are responsible for a decrease of the GTPase activity of the ras protein, which stays then in active conformation bound to the GTP. This leads to the blocking of the pathway and to the inactivity of the pharmacological blocking of EGFR.

Eligibility: Inclusion Criteria:
  -  for the study of the KRAS mutation: 250 patients drawn by lots among the cases of colorectal carcinoma diagnosed between January 1st, 2007 and December 31st, 2009 in Martinique
  -  for the study of incidence: patient for whom was diagnosed a colorectal carcinoma between January 1st, 2007 and December 31st, 2009
  -  patient unopposed and in free agreement to participate in this study
  -  patient having his main home in Martinique at the time of the diagnosis
  -  patient 18 years old and over
  Exclusion Criteria:
  -  patient whose diagnosis is prior to 2007 and later in 2009
  -  patient having shown opposition to the participation in this study
  -  patient minor or under guardianship
  -  patient not having his main home in Martinique at the time of the diagnosis

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 Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Summary: This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.


Eligibility: Inclusion criteria:
  1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
  2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
  Exclusion criteria:
  1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
  2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
  3. Known pre-existing interstitial lung disease.
  4. Planned major surgical procedures during the trial period.

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

Clinical trial: Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

Summary: The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.
  The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

Detailed description: The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.

Eligibility: Inclusion Criteria:
  1. Adults (≥ 18 years) at the time of signing informed consent form
  2. Understand and voluntarily sign informed consent form
  3. Able to adhere to study visit schedule and other protocol requirements
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  5. Absolute neutrophil count ≥ 1500 / mm³
  6. Platelet count ≥ 100,000 / mm³
  7. Resectable pancreatic adenocarcinoma
  8. Pathologic diagnosis of pancreatic adenocarcinoma
  Exclusion Criteria:
  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
  2. A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
  3. Presence of active infection
  4. Untreated second malignancy
  5. Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)

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

Clinical trial: Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

Summary: The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.


Eligibility: Inclusion Criteria:
  -  The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
  -  Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
  -  The subject has a radiographically measurable tumor.
  -  The subject is able to carry out daily life activities without difficulty.
  -  The subject is able to swallow and retain oral medication.
  -  The subject does not have significant side effects from previous anti-cancer treatment.
  -  The subject has adequate organ and blood cell counts.
  -  Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
  Exclusion Criteria:
  -  The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
  -  The subject has a brain tumor.
  -  Current severe, uncontrolled systemic disease.
  -  History of clinically significant heart, lung, or eye/vision problems.
  -  The subject has high blood pressure that is not well-controlled with medication.
  -  The subject has a permanent pacemaker.
  -  The subject is pregnant or breastfeeding.
  -  Positive for Hepatitis B, Hepatitis C, or HIV.

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

Clinical trial: Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Summary: GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.
  The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.
  Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.
  Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
  The patients will be subjected to research for the EGFR, HER2 and KRAS status.


Eligibility: Inclusion Criteria:
  -  Metastatic pancreatic adenocarcinoma confirmed by histology
  -  Tumor sample available
  -  Measurable lesion according to RECIST criteria
  -  Performance status ≥ 1
  -  Life expectancy > 3 months
  -  Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  -  Renal function: creatinine ≤ 1.5 x ULN
  -  Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
  -  Left ventricular ejection fraction (LVEF) ≥ 50%
  -  At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
  -  Social security
  -  Informed consent obtained prior to inclusion.
  Exclusion Criteria:
  -  Non metastatic advanced local disease
  -  Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
  -  Others cancers except BBC and cervical cancer receiving curative treatment
  -  No previous treatment by Erlotinib or Trastuzumab
  -  Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
  -  Presence of significant co-morbidities
  -  Concomitant treatment with other experimental products or other anticancer therapies
  -  Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
  -  Legal incapacity or limited legal incapacity

Relevance to patient case: definitely relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

Summary: The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.

Detailed description: Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
  -  Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
  -  Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
  -  Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) —OR— Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.
  Exclusion Criteria:
  -  Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
  -  Positive surgical margins.
  -  Lack of clinical followup at one year following surgery

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

Clinical trial: Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Summary: Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.


Eligibility: Inclusion Criteria:
  -  Untreated metastatic colorectal carcinoma
  -  Age 18 yrs or over
  -  Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
  -  ECOG performance status 0 or 1
  -  Life expectancy more than 3 months
  -  Adequate haematological, renal and liver function
  -  Tumor tissue available for determination of KRAS mutational status
  -  Blood sample and paraffin embedded tumor tissue for translational research
  Exclusion Criteria:
  -  Adjuvant therapy within 6 months
  -  CNS metastases
  -  Clinically significant atherosclerotic vascular disease

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

Clinical trial: Nerve Growth Factor in Chronic Pancreatitis

Summary: This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.
  Hypothesis:
  1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
  2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.


Eligibility: Inclusion Criteria:
  -  Patients with established CP and none of the exclusion criteria mention below.
  Exclusion Criteria:
  -  Failure to obtain consent.
  -  Any comorbid condition with expected survival < 1 year.
  -  Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.
  -  Patients < 18 years of age at time of 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: Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

Summary: No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Detailed description: Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility: Inclusion Criteria:
  -  Diagnosis of pancreatic cancer
  -  Preoperative chemotherapy
  -  Pancreatic resection
  Exclusion Criteria:
  -  Metastatic disease
  -  ASA score 4

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

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Study of Circulating Tumoral DNA in Ovarian Cancer

Summary: Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Detailed description: Technique development:
  In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.
  Validation:
  The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.
  The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Eligibility: Inclusion Criteria:
  -  Age > or = 18 years.
  -  Patient with invasive ovarian cancer stage II to IV from FIGO classification.
  -  Patient treated by surgery.
  -  Patient with tumor or metastasis available for TP53 status characterization
  -  Patient able to stand a blood collection.
  -  Signed written informed consent approved by AFSSAPS and CPP.
  Exclusion Criteria:
  -  Patient without social protection / insurance.
  -  Borderline ovarian tumor.
  -  Non carcinoma ovarian tumor
  -  Patient with invasive ovarian cancer 5 years before diagnosis
  -  Current pregnancy and lactation.
  -  All social, medical, psychological, situations making the study impossible.
  -  Person deprived of liberty.

Relevance to patient case: not relevant