araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors. It is not yet known whether fluorouracil is more effective when given together with leucovorin and/or levamisole after surgery in treating colon cancer.
  PURPOSE: This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes' B or Dukes' C colon cancer.

Detailed description: OBJECTIVES: I. Compare, in a Phase III setting, disease-free survival and overall survival of patients who have undergone potentially curative resection of Dukes' B or C carcinoma of the colon randomly assigned to adjuvant therapy with 5-fluorouracil/leucovorin vs. 5-fluorouracil/levamisole vs. 5-fluorouracil/leucovorin/levamisole.
  OUTLINE: Randomized study. Arm I: Single-agent Chemotherapy with Drug Modulation. 5-Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590. Arm II: Single-agent Chemotherapy with Drug Modulation plus Biological Response Modifier Therapy. 5-FU; with CF; plus Levamisole, LEV, NSC-177023. Arm III: Single-agent Chemotherapy plus Biological Response Modifier Therapy. 5-FU; plus LEV.
  PROJECTED ACCRUAL: 1,800 evaluable patients will be accrued over about 3 years; an additional 2 years will be required before final analysis.

Eligibility: DISEASE CHARACTERISTICS: See General Eligibility Criteria
  PATIENT CHARACTERISTICS: See General Eligibility Criteria

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps

Summary: RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.
  PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.

Detailed description: OBJECTIVES:
  Primary
  -  Determine if folic acid supplementation lowers the adenoma recurrence rate.
  Secondary
  -  Determine the number of adenomas per patient and the size and histology of the adenoma.
  -  Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.
  -  Assess the interaction between folic acid and pretrial and midtrial folate levels.
  -  Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.
  OUTLINE: Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive oral folic acid once daily.
  -  Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.

Eligibility: DISEASE CHARACTERISTICS:
  Inclusion criteria:
  -  Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum
  -  Plan on having an endoscopy within 4 years after initiation of the trial
  -  Must release medical records regarding past and any future endoscopies
  PATIENT CHARACTERISTICS:
  Inclusion criteria:
  -  Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L
  Exclusion criteria:
  -  Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer
  -  Diagnosis of homocystinemia
  -  Diagnosis of pernicious anemia
  -  Any gastrointestinal disorder that could lead to a vitamin B12 deficiency
  -  Diagnosis of cirrhosis or pancreatitis
  -  Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning
  PRIOR CONCURRENT THERAPY:
  Exclusion criteria:
  -  No prior gastrectomy, total colectomy, or pancreatectomy
  -  Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins)
  -  No concurrent methotrexate or anticonvulsant

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

Summary: Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Detailed description: Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  Exclusion Criteria:
  -  Histology showing other than adenocarcinoma

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

Summary: The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
  -  Subjects must have:
  1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
  2. a documented T790M EGFR mutation
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1.
  -  Sexually active subjects must use an accepted method of contraception during the course of the study.
  -  Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
  Exclusion Criteria:
  -  Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
  -  Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
  -  Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
  -  Receiving anticoagulation therapy with warfarin.
  -  Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
  -  Corrected QT interval (QTc) of >0.45 seconds.
  -  Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
  -  Requires steroid or anticonvulsant therapy for the treatment of brain metastases.

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: NYU Ovarian Cancer Early Detection Program Blood and Genetics

Summary: Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.

Detailed description: The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.
  This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.

Eligibility: Inclusion Criteria:
  Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
  -  A personal history of breast cancer
  -  One or more first degree relatives (mother, sister, daughter) with ovarian cancer
  -  Multiple family members with either breast and/or ovarian cancer
  -  A personal history of a positive BRCA1 or BRCA2 genetic test result
  -  A close relative with a positive BRCA1 or BRCA2 genetic test result
  -  A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
  -  Synchronous or metachronous endometrial and colorectal cancer
  -  A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
  -  A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
  -  A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
  -  The use of fertility drugs for more than one year

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Anonymous Testing of Pathology Specimens for BRCA Mutations in Ashkenazi Jewish Individuals Who Have Cancer

Summary: The intent of the proposed study is to describe the prevalence of the most common recurring mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish individuals with a variety of cancer diagnoses. If a substantial proportion of these samples contain such mutations, future patients presenting with these diseases may wish to undergo genetic counseling and, if appropriate, formal genetic testing. The benefit from such a process would pertain mainly to the families of these individuals.

Detailed description: Germline mutations in the genes BRCA1 and BRCA2 have been demonstrated in the majority of hereditary breast and ovarian cancer families. The increased risk to develop both breast and ovarian cancer associated with inheriting a BRCA1 or BRCA2 mutation has been well established. It has also been suggested that is an overrepresentation of other cancers such as colon, prostate and pancreatic cancer present in BRCA1 or BRCA2 families. Population specific mutations in BRCA1 and BRCA2 have been identified. In the Ashkenazi Jewish population, 3 specific mutations have been seen in 2% of the population. This study will anonymously screen archived tissue samples of Ashkenazi Jewish individuals diagnosed with cancer between 1993 and 1996 at MSKCC for the three founder mutations seen in the Ashkenazi Jewish population. Results will be stratified by tumor type and compared with the population frequency to determine whether individuals inheriting mutations in BRCA1 or BRCA2 may have an increased risk to develop other cancers, in addition to breast and ovarian cancer. This information will be useful in helping to identify individuals who may benefit from genetic counseling and possibly genetic testing who to date are not typically referred. It will also be useful in developing high-risk cancer screening strategies and determining appropriate options for prophylactic surgery.

Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer made at MSKCC or collaborating institutions, AND
  -  Tissue block of tumor or normal margin or extracted DNA available for study and sufficient material present to allow study without exhausting block or DNA,
  -  Individual self-identified as Jewish on intake.

Relevance to patient case: not relevant
Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

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: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

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: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

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