araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

Summary: This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation


Eligibility: Inclusion Criteria:
  -  A positive diagnosis of IBS.
  -  Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
  -  contraception.
  -  Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent
  Exclusion Criteria:
  -  History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
  -  Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
  -  Evidence of occult blood at stool analysis, or history of rectal bleeding.
  -  Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase I/II Combination With Irinotecan- Erbitux

Summary: Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
  Part 2: To compare median duration of progression free survival (PFS)


Eligibility: Inclusion Criteria:
  -  Biopsy proven MCRC
  -  Prior irinotecan allowed
  -  Prior Erbitux allowed
  Exclusion Criteria:
  -  No prior brivanib
  -  No prior combination of irinotecan with Erbitux
  -  No secondary malignancies
  -  No anti-coagulation therapy
  -  No prior history of blood clots requiring anti-coagulation

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

Summary: To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
  -  Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  Exclusion Criteria:
  -  Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
  -  Prior surgery or investigational agent within 4 weeks prior to study entry.
  -  Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Hereditary Colorectal and Associated Tumor Registry Study

Summary: After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.


Eligibility: Inclusion Criteria:
  -  Identified gene mutation
  -  Personal history of colorectal cancer diagnosed ≤ 50
  -  Personal history of cancer with tumor studies suggestive of Lynch syndrome
  -  Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
  -  Personal history of one of the above cancers and a family history of one or more of the above cancers
  -  Personal or family history of diffuse gastric cancer
  -  From a known genetic predisposition family
  -  Personal history of > 10 colon adenomas (cumulative over a lifetime)
  -  Personal history of any number of hamartomatous polyps
  -  Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid
  Exclusion critera:
  -  Individuals under the age of 8
  -  Individuals who cannot travel to Pittsburgh for in-person enrollment
  -  Individuals who cannot provide informed consent

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

Summary: RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
  PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
  Secondary
  -  To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
  OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
  Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets any of the following criteria:
  -  Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
  -  Patients who meet Amsterdam I, II, or Bethesda criteria
  -  Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
  -  Patients diagnosed with colorectal cancer at < 50 years old
  -  Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Proton Therapy for Unresectable Cancer (CA) of Pancreas

Summary: The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

Detailed description: Chemotherapy:Capecitabine on radiation days
  Proton radiation over 7 weeks
  Consolidation Chemotherapy:Gemcitabine

Eligibility: Inclusion Criteria:
  Pathologically confirmed adenocarcinoma of the pancreas.
  Patients must be medically inoperable or have unresectable disease
  Exclusion Criteria:
  -  Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
  -  Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
  -  Prior surgical resection.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

Summary: Epigenomics is developing a colon cancer screening assay based on differential methylation of specific CpG sites for the detection of early stage disease. A genome-wide methylation analysis and oligonucleotide array study using DNA from various stages of colon cancer and normal tissue have been completed to obtain candidate CpG markers. Based on results obtained in the above studies, Epigenomics has moved to the final stages of feasibility with a specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in blood plasma.

Detailed description: From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
  Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Group 1 diagnosis of colorectal cancer
  Exclusion Criteria:
  -  Group 2 diagnosis of colorectal cancer

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

Summary: The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use

Detailed description: Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines.
  Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib.
  The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use.
  Therefore, the following information is of particular interest in the course of the investigation:
  -  Efficacy (best response, overall survival, progression-free survival)
  -  Tolerability of the therapy (assessed by the physician)
  -  Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta®
  -  Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta®
  -  The sequence of using the systemic therapies for RCC, MCL, and GIST
  -  Patient survey on the quality of life of mRCC patients

Eligibility: Inclusion Criteria:
  -  Patients with proven tumor of RCC, MCL or GIST by histology.
  -  Informed consent signed by patient.
  Exclusion Criteria:
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Colorectal Cancer Screening Validation Study

Summary: The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.


Eligibility: Inclusion Criteria:
  -  willing to provide informed consent
  -  greater than or equal to 50 years of age
  -  patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
  -  subject is willing to provide colorectal mucosal sample for gene expression testing
  Exclusion Criteria:
  -  recent radiation or treatment for gynecologic, prostate or rectal cancer
  -  recent surgery for anal rectal disease
  -  polys, family or self history of cancer (control group only)
  -  GI disease
  -  any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Colonography Versus Colonoscopy in High Risk Patient

Summary: to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.

Detailed description: Secondary objective: to evaluate the medical and economic impact of the implementation of CT- colonography in this setting.Methodology: prospective multicenter randomized controlled trial with direct patient benefitN° of patients to be included: 600 Study follow-up :1 consultation and 3 phone contacts (M1, M6 and M12)Evaluation criteria:Main endpoint: acceptability of the colorectal cancer screening (% of enrolled patients having actually undergone the exploration)Secondary endpoints: - cost/effectiveness ratio of the 2 diagnostic tests with calculation of the economic and medical costs. - number of advanced adenoma detected in each group- number of CRC cases detected in each group

Eligibility: Inclusion Criteria:
  Surveillance of patients with a personal history of advanced adenoma or CRC:
  -  Informed consent obtained
  -  Age ≥ 18 and ≤ 80 years old
  -  History of advanced adenomatous polyps
  -  Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment.
  -  Previous medical examination
  Screening of patients with a Family history of CRC at high risk:
  -  Informed consent obtained
  -  Age ≥ 18 and ≤ 80 years old
  -  First degree family history of colorectal cancer diagnosed <60yrs during the five previous years-Previous medical examination
  Exclusion Criteria:
  Personal histories
  -  Age < 18 or >80 years old
  -  history of non adenomatous polyps
  -  history of Metastatic CRC
  -  familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome
  -  Familial history of familial adenomatous polyposis
  -  Personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria)
  -  Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment.
  -  Enrollment in another protocol
  -  no health insurance affiliation Family histories
  -  Age < 18 or >80 years old
  -  Patients with one or several family histories of first degree colorectal cancer occured to unknown age or diagnosed after 60 years old.
  -  Eligible patients having already undergone colonoscopy screening
  -  no health insurance affiliation

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study of Genes and the Environment in Patients With Colorectal Cancer in the East Anglia Region of the United Kingdom

Summary: RATIONALE: Studying samples of blood 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 study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with colorectal cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population based series of colorectal cancer cases.
  -  To define the proportion of colorectal cancer incidence attributable to mutations in known predisposing genes such as MLH1 and MSH2.
  -  To establish whether mutations at other loci may predispose to colorectal cancer, by comparing the frequency of alteration candidate genes in colorectal cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire. The questionnaire also requests identifying information about the patient's first-degree relatives.
  Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the colorectal cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain, and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colorectal cancer within the past 5 years
  -  Identified in the East Anglia region of the United Kingdom
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

Summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  -  Mutant-type KRAS tumor at screening
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  -  Adequate hematology, renal, hepatic, and coagulation function
  Exclusion Criteria:
  -  History or known presence of central nervous system metastases
  -  History of other malignancy
  -  Prior irinotecan-based chemotherapy for advanced/metastatic disease
  -  Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  -  Uncontrolled cardiovascular disease

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?

Summary: The purpose of this randomised intervention study is to investigate to what degree patients with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic treatment and quality of life.


Eligibility: Inclusion Criteria:
  -  metastatic colorectal cancer
  -  histological verified cancer
  -  age >18 years
  Exclusion Criteria:
  -  cognitive reduction
  -  confusion
  -  not able to answer questionaire

Relevance to patient case: not relevant