araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

Summary: RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.
  PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

Detailed description: OBJECTIVES:
  -  Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery .
  OUTLINE: Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks.
  -  Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks.
  Biological samples are collected for gene expression analysis for identification of predictive markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of colon
  -  Stage III (T1-4, N1-3, M0) disease
  -  Has undergone surgical resection of the tumor within the past 8 weeks
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Able to take medications orally
  -  WBC ≥ 3,500/mm³ and < 12,000/mm³
  -  ANC ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Hemoglobin ≥ 9.0 g/dL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  AST/ALT ≤ 100 IU/L
  -  Creatinine ≤ 1.2 mg/dL
  -  No other active malignancies
  -  Must have none of the following comorbidities:
  -  Severe postoperative complications
  -  Uncontrollable diabetes mellitus
  -  Uncontrollable hypertension
  -  Myocardial infraction within 6 months
  -  Unstable angina pectoris
  -  Hepatocirrhosis
  -  Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy for colon cancer
  -  No concurrent radiotherapy
  -  No concurrent biological response modifiers

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C

Summary: The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy according to the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.

Detailed description: Mangafodipir, manganese (Mn) dipyridoxyl diphosphate, is a catalytic antioxidant and iron chelator recently (2006) suggested for cancer treatment in an Editorial in Journal of the National Cancer Institute. Preclinical research has shown that mangafodipir protects normal tissues without loss of anti-tumour activity during chemotherapy. Other advantages are that mangafodipir is already approved for use in patients as a contrast agent for magnetic resonance imaging (MRI) of liver, and that the experience for more than a decade reveals high safety with mainly minor and tolerable side-effects.
  The present study will include 14 patients who will be followed throughout 3 treatment cycles. Each cycle will be preceded by infusion of mangafodipir or placebo in two groups, each consisting of 7 patients. The primary endpoints will be the most frequent manifestation of FOLFOX6, namely neutropenia and neurosensory toxicity. The secondary endpoints will be the frequency and severity of other FOLFOX6-related adverse events and quality of life.

Eligibility: Inclusion Criteria:
  1. Histologically proven colon cancer stage Dukes' C.
  2. Patient over 18 years.
  3. WHO performance status <1.
  4. Adequate haematological function (Hb ≥ 100 g/L, ANC ≥ 2.0 x 109/L, platelets ≥ 150 x 109/L)
  5. Adequate renal and hepatic functions: serum creatinine and total bilirubin ≤ 1.25 times upper normal limits (ASAT and ALAT ≤ 3 times upper normal limits)
  6. Clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy
  7. Use of adequate contraception (males with reproductive potential)
  8. Written informed consent given
  Exclusion Criteria:
  1. Other tumour types than colon adenocarcinomas
  2. Current severe neutropenia, leucopenia or thrombocytopenia
  3. Severely reduced liver or renal function
  4. Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn's disease or ulcerative colitis
  5. Current chronic diarrhoea
  6. Contraindication for corticosteroid administration
  7. History of prior serious allergic or pseudo-allergic reaction
  8. Any other serious illness or medical condition
  9. Symptomatic peripheral neuropathy ≥ grade 2
  10. Received mangafodipir ≤ 5 weeks before planned start of chemotherapy
  11. Received any of the FOLFOX drugs ≤ 5 weeks before planned start of chemotherapy
  12. Any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study
  13. Fertile females
  14. Males with reproductive potential not implementing adequate contraception measures
  15. Phaeochromocytoma

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). 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 male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Lactobacillus Plantarum 299v in Colon Surgery

Summary: Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.


Eligibility: Inclusion Criteria:
  -  planned resection of colon for malignant or benign disease
  -  all ages
  Exclusion Criteria:
  -  unable to understand instructions and perform preoperative intake of study preparation
  -  rectal surgery
  -  present or past history of endocarditis
  -  congenital or acquired valvular heart disease

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). 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 male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

Summary: This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Detailed description: Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Eligibility: Inclusion Criteria:
  -  Biopsy proven of colon cancer
  -  Preoperatively suspected as clinical stage III colon cancer
  -  Lesion located Descending colon, sigmoid colon and upper rectal cancer
  Exclusion Criteria:
  -  Could not perform curative resection
  -  Intestinal obstruction, perforation, intra-abdominal abscess
  -  Severe medical illness
  -  Immunopathy

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
  -  Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  -  Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  -  Men or women 18 years of age or older
  -  Adequate hematologic, renal, hepatic, metabolic, and coagulation function
  Exclusion Criteria:
  -  History of prior or concurrent central nervous system (CNS) metastases
  -  Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  -  Clinically significant cardiac disease
  -  Clinically significant peripheral sensory neuropathy
  -  Active inflammatory bowel disease
  -  Recent gastroduodenal ulcer to be active or uncontrolled
  -  History of interstitial lung disease
  -  Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  -  Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  -  Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

Summary: The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.
  Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.


Eligibility: Inclusion Criteria:
  -  Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology.
  -  Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded).
  -  Patient's informed consent
  Exclusion Criteria:
  -  Prior intrabdominal tumor surgery
  -  Other preexisting malignancies
  -  Hypersensitivity/allergy to dye (isosulfan blue)
  -  Pregnancy
  -  Breast-feeding
  -  No patient's informed consent

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Exploratory Study Of The ERCC-1 Gene

Summary: This study is for patients with advanced or stage II and III colon or rectal cancer. The primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of colorectal cancer.
  -  ECOG Performance Status 0-2 (Appendix A).
  -  Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.
  -  Consent to donate 4 tubes of PBMC of 7 ml of blood each.
  -  Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).
  -  Adequate organ function as defined as:
  -  Neutrophil count > 1500/μl
  -  Platelets > 75,000/ μl
  -  Hemoglobin > 8 g/dl
  -  Bilirubin < 2.0 X upper limit of normal
  -  Creatinine < 2 mg% or calculated clearance > 40 ml/mt
  -  The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB
  Exclusion Criteria:
  -  No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.
  -  Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.
  -  Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).
  -  Patients with grade 2 neuropathy will not be eligible for the study.
  -  The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Pilot Study of Colon Cancer Screening Tests

Summary: Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.


Eligibility: Inclusion Criteria:
  -  All individuals age 50 to 70 years
  Exclusion Criteria:
  -  Unable to give informed consent
  -  History of colorectal cancer
  -  History of adenomatous polyp
  -  History of inflammatory bowel disease
  -  Prior participation in FOBT screening
  -  Prior refusal to participate in FOBT screening
  -  Flexible sigmoidoscopy within the previous 3 years
  -  Virtual colonoscopy within the previous 3 years
  -  Optical colonoscopy within the previous 3 years
  -  Severe of terminal illness that would preclude benefit from colon cancer screening

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

Summary: RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Detailed description: OBJECTIVES:
  -  Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
  -  Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
  -  Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.
  OUTLINE: This is a pilot study.
  Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Immunoreactivity to Cetuximab in Cancer Patients

Summary: RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.
  PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

Detailed description: OBJECTIVES:
  -  To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.
  OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following:
  -  Head and neck cancer
  -  Advanced colorectal cancer
  -  Previously treated with cetuximab
  -  Serum samples available from patients enrolled in one of the following clinical trials:
  -  VU-VICC-GI-0410 (colorectal cancer)
  -  VU-VICC-GI-0622 (colorectal cancer)
  -  VU-VICC-HN-0356 (head and neck cancer)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant