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

Clinical trial: Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Summary: Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.


Eligibility: Inclusion Criteria:
  -  patients with a 1st degree familial history of pancreas adenocarcinoma
  -  patients older than 40
  -  patients whose life expectancy is > 3 months
  -  inform and consent form signed
  -  patient insured under the French social security system
  Exclusion Criteria:
  -  contraindication to the MRI (pace-maker, implanted metallic material, medical history of allergy to the contrast agent, end-stage renal failure, pregnancy, claustrophobia)
  -  contraindication to anesthesia to do the echo endoscopy
  -  1st degree family history of 2 pancreas adenocarinomas
  -  medical history of allergy to benzylic alcool
  -  contraindication to dimeglumine gadobenate
  -  pregnant or breastfeeding woman, according to the questioning
  -  subjets who don't have the legal capacity to 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: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

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

Clinical trial: Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Summary: This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).

Detailed description: Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover. Characteristic of the malignant process, ctDNA can be assessed in plasma and offers the potential of a sensitive and specific biomarker for prognostic information on disease-free or overall survival, and predictive information on chemotherapy resistance and probability of lack of response to treatment. This study will evaluate ctDNA as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC). We will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (>10 ml), serial plasma specimens every 3 months for up to 3 years and every 6 months in years 4-5 for ctDNA and concurrent carcinoembryonic antigen (CEA) measurement. Clinical outcome and survival will be tracked. The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival and as a monitor of disease recurrence in comparison with CEA.

Eligibility: Inclusion Criteria:
  -  Men and women with CRC Stage III A, B, or C
  -  Age ≥18 years
  -  Willingness to provide blood samples for research purposes
  -  Ability to understand written informed consent document, and written informed consent provided
  Exclusion Criteria:
  -  Blood sampling would compromise patients overall health such as presence of severe anemia
  -  Unable to give 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: Study on Fluids Associated to Lung Cancer

Summary: The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).
  This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.
  The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.


Eligibility: Inclusion Criterias :
  -  Patients with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1).
  -  Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2).
  -  Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3).
  -  Adults patients : over 18 years.
  -  Persons affiliated to national social security.
  -  Free signed consent.
  Exclusion Criterias :
  -  Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.

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

Clinical trial: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Summary: Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
  In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

Detailed description: The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
  The secondary objectives of this study will be:
  -  Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  -  Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Eligibility: Inclusion Criteria:
  -  patient with melanoma confirmed histologically
  -  patient with metastatic melanoma (stage III unresectable or stage IV)
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  - Metastatic tumor whose origin is doubtful (uncertain melanoma)

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

Clinical trial: Diffusion MRI for Pancreatic Adenocarcinoma

Summary: The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up


Eligibility: Inclusion Criteria:
  -  age > 18 year old,
  -  no general contraindication for pancreatic surgery,
  -  pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
  -  CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
  -  Resectability confirmed by a medical/surgical multidisciplinary review,
  -  if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
  -  informed consent prepared and signed.
  Exclusion Criteria:
  -  locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
  -  unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
  -  metastasis of any organ visible on thoraco-abdominopelvic CT scan
  -  time lag exceeding 21 days between diffusion-weighted MRI and surgery
  -  contraindication for an MRI

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

Clinical trial: Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer

Summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Detailed description: In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
  So in this study, we will collect ctDNA of pancreatic cancer patients who underwent operation, and will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

Eligibility: Inclusion Criteria:
  -  Pancreatic cancer patients who progress EUS-FNA for pancreatic cancer diagnosis
  -  Pancreatic cancer patients who are in operable stage.
  Exclusion Criteria:
  -  Foreigners
  -  Pancreatic cancer patients who have other cancer
  -  Patients who impossible to consent to study by own

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

Clinical trial: Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma

Summary: In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
  Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
  The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  stage I lung adenocarcinoma
  Exclusion Criteria:
  -  cases with any new adjuvant treatment prior to 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: Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

Summary: This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment of certain types of colorectal cancer as well as head and neck cancer.
  The major aims of the study are: (Phase 1b) to define the safety profile and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients with advanced colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histological Diagnosis
  -  Phase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
  -  Phase 2:
  -  KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
  -  KRAS Wild Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody, such as cetuximab, panitumumab or others.
  -  Adequate performance status and hematological, liver, and kidney function
  -  Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents.
  -  Phase 2 only: second malignancy within the last 3 years.
  -  Known active or chronic hepatitis B or C infection or HIV
  -  Pregnancy or active breastfeeding

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

Clinical trial: Study of LXH254 and LTT462 in NSCLC

Summary: To characterize safety and tolerability of LXH254 and LTT462 combination and identify a recommended dose and regimen.


Eligibility: Inclusion Criteria:
  -  Patients must have advanced or metastatic NSCLC
  -  Presence of KRAS or BRAF mutation in tumor tissue
  -  All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  Exclusion Criteria:
  -  Dose expansion - Group 1: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. Group 2: Prior treatment with an ERKi and/or a pan-RAFi.
  -  History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  -  Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
  -  Patients with Gilbert's syndrome or other heritable diseases of bile processing.
  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: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma positive EBUS-TBNA specimen
  Exclusion Criteria:
  -  other 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: Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma

Summary: The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the follow-up.


Eligibility: Inclusion Criteria:
  -  All patients consecutive enrolled from January 2009 to December 2015 who underwent at least one chemotherapy for pancreatic adenocarcinoma, whatever the stage
  Exclusion Criteria:
  -  A patient record captured outside the time frame from January 2009 to December 2015

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

Clinical trial: Management of Symptomatic Advanced Pancreatic Adenocarcinoma

Summary: This study assessed the feasibility and effects of an early integrative supportive care program in patient with Advanced pancreatic adenocarcinoma (aPDAC).

Detailed description: Two-step cohort study:
  * Step 1 : A 14-day integrative supportive care program initiated as early as the clinical suspicion of aPDAC.
  According to the investigator's assessment of patient needs, this integrative supportive care program will include:
  -  management of pain
  -  nutritional support
  -  pathologic diagnosis (endoscopy guides or percutaneous biopsies or ascitis cytology)
  -  diagnostic computed imaging
  -  endoscopic stenting of the bile duct and/or duodenum
  * Step 2 : Follow up after the integrative supportive care program. According to their Eastern Cooperative Oncology Group Performance Status(ECOG PS) and/or chemotherapy
  -  Group 1 : Patient becoming eligible for treatment with FOLFIRINOX or nab-paclitaxel + gemcitabine and / or clinical trial
  -  Group 2 :Patient at the end of the 14-day program (Step 1) remaining with either :
  a - Persisting ECOG PS ≥ 2
  b - Clinico-biological features that make them ineligible to receive the FOLFIRINOX or nab-paclitaxel + gemcitabine regimens
  c - Patient ineligible to other therapeutic clinical trial

Eligibility: Inclusion Criteria - STEP 1:
  1. Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,
  2. Age ≥ 18 years,
  3. Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
  4. No prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer.
  5. Registration in France with the French National Health Care System (CMU included)
  6. Patient able to comply with study protocol requirements in the view of the investigator,
  7. Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
  8. Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).
  Exclusion Criteria - STEP 1 :
  1. Any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
  2. Patient protected by law,
  3. Pregnant or breast feeding women

Relevance to patient case: not relevant