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

Clinical trial: An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer

Summary: EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of Colon Cancer, stage III
  -  At least four weeks following prior standard treatment, with no evidence of disease
  -  Must use adequate birth control
  Exclusion Criteria:
  -  Prior cancer vaccine therapy or concurrent participation in any other investigational study
  -  A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
  -  A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
  -  Women who are pregnant, intend to become pregnant, or who are breast feeding

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

Clinical trial: Genetic Study of Familial Factors in Patients With Colon Cancer

Summary: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
  PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Detailed description: OBJECTIVES:
  -  Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
  -  Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
  -  Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
  -  Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer or polyps at age 70 or under
  -  Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
  -  No history of familial adenomatous polyposis syndrome
  -  No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
  -  No known I1370K adenomatous polyposis of the colon susceptibility variant
  -  Enrolled on 1 of the following clinical trials:
  -  CLB-9581
  -  CLB-89803
  -  CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.
  PATIENT CHARACTERISTICS:
  Age
  -  70 and under at diagnosis
  Other
  -  No significant psychiatric illness that would preclude giving informed consent
  -  No inflammatory bowel disease (in patient or sibling)

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

Clinical trial: Preoperative Assessment of Colon Tumor

Summary: The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.


Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  -  Colorectal tumor
  Exclusion Criteria:
  -  Active diverticulitis
  -  Pacemaker
  -  Metal in the body
  -  Claustrophobia

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

Clinical trial: Study Evaluating Isovorin in Colon Cancer

Summary: The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.


Eligibility: Inclusion Criteria:
  -  Dukes C, Cure A colon cancer diagnosed histologically or cytologically
  -  Normal organ function of bone marrow, heart, liver and kidney
  -  Age 20-75
  Other inclusion applies
  Exclusion Criteria:
  -  Serious bone marrow suppression, infection, heart disease or complication
  -  Familial adenomatous polyposis or hereditary nonpolyposis
  -  Pregnant or breastfeeding women
  Other exclusion applies

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

Clinical trial: The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

Summary: The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a colon prep for a colonoscopy will decrease the side effects that are associated with the colon preparation

Detailed description: The high incidence for colon cancer make it an ideal target for screening. In the United Staes there are approximately 100,00 new cases of colon cancer yearly. Typically the progression from polyps to cancer requires years. This permits a screening procedure to identify polyps befoere they are cancerous. Colon cleansing is required prior to colonoscopy. The gastrointestinal syptoms associted with colonic preps are common and oftn assoicated wwith upper gastrointestinal disorders including GERD, non-ulcer syspepsia, and gastric dysmotoility such as gastropareesis.

Eligibility: Inclusion Criteria:
  -  Subject 18 or older undergoing out-patient colonoscopy
  Exclusion Criteria:
  -  Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.

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

Clinical trial: Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Summary: 1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
  2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
  3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Detailed description: RATIONALE: Many studies have tested the combination of cisplatin and irinotecan. Side effects have been well described. The two drugs are synergistic.
  The standard of care for colon cancer is the combination of 5-FU, leucovorin and irinotecan (Saltz regimen). Recently, oxaliplatin has been introduced for the treatment of colon cancer. Combination of oxaliplatin with 5FU (Folfox4) have shown comparable activity to the Saltz regimen. Furthermore, one author recently published on the triple combination of oxaliplatin, 5FU and irinotecan, with impressive clinical activity in colon cancer.
  There is some evidence that 5FU impairs DNA repair. One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair. We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan.
  This study is open to all patients with solid tumor who have failed a line of chemotherapy

Eligibility: Inclusion Criteria:
  -  All patients, 18 years of age or older, with incurable advanced cancer for whom there is no effective therapy are eligible.
  -  Patients must have a life expectancy of at least 12 weeks.
  -  Patients must have a Zubrod performance status of 0-2.
  -  Patients must sign an informed consent.
  -  Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
  -  Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
  Exclusion Criteria:
  -  Patients with symptomatic brain metastases are excluded from this study.
  -  Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  -  Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
  -  Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
  -  Patients whose cancer progressed while receiving 5-FU, cisplatin or irinotecan.

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

Clinical trial: Resveratrol for Patients With Colon Cancer

Summary: Resveratrol is purported to possess cancer preventive activity, especially for colon cancer, though its mechanisms of action are not well defined. Resveratrol is found in the skin of grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The main dietary sources of resveratrol are grapes, grape products, and red wine, and small amounts may be found in mulberries. A prior report and compelling preliminary data from our laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is activated in over 85% of colon cancers. In this proposal, studies were performed to define the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients with colon cancer received treatment with Resveratrol, and correlative laboratory studies examined its effects directly on colon cancer and normal colonic mucosa. These studies provided data on the mechanisms of resveratrol action and provided a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.

Detailed description: Patients will be treated with a two-week course of resveratrol. The initiation of the treatment will be approximately 14 days before standard of care surgical resection of tumor. Resveratrol will be ingested as 20 mg pills or in the form of freeze-dried grape extract which is prepared by the California Table Grape Commission used under GMP guidelines for human consumption.
  The first two patients receiving resveratrol will be treated at a dose of 20 mg/day, the third and fourth patients at a dose of 80 mg/day, and the fifth and sixth patients with a dose of 160 mg/day. All patients receiving grape extract will receive 125 mg/day that will have to be mixed with one 8 oz glass of water. There will be no dose adjustments. If a patient has any side effects which are attributed to the resveratrol, it will be discontinued.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with colon cancer by colonoscopic biopsy and tissue obtained under UCI04-05.
  -  Patients with a plan for surgical resection at UCIMC within 2-4 weeks of enrollment.
  Exclusion Criteria:
  -  Surgical resection to be performed at a facility other than UCIMC.
  -  Patients under 18 years of age.

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

Clinical trial: Cellular Immune Augmentation in Colon and Rectal Cancer

Summary: While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Eligibility: Inclusion Criteria:
  -  Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
  -  Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
  -  Patient must be able to be taught to administer GM-CSF subcutaneously
  Exclusion criteria:
  -  Known allergic or other adverse reaction to GM-CSF
  -  Chemotherapy administration more frequently than bi-weekly
  -  Pregnant or lactating women

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

Clinical trial: Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Summary: This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time following surgery for colon carcinoma Stage II.


Eligibility: Inclusion Criteria:
  -  Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
  -  Age: less than 80 years
  -  WHO Performance > 2
  -  Adequate bone marrow reserve, renal and hepatic functions
  -  Informed consent
  Exclusion Criteria:
  -  Rectal cancer
  -  R1or R2 resection; carcinosis peritonei
  -  Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  -  Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma

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

Clinical trial: Frequency of Circulating Tumour Cells in Stage II and Stage III Colon Cancer Patients

Summary: This study will determine whether a new diagnostic test called the Cell Search Assay can detect circulating colon cancer cells in patients who have had surgery for colon cancer and had visible cancer removed. Other parts of the study will look at whether the presence of the circulating tumor cells in blood predicts whether a patient will have their colon cancer return.


Eligibility: Inclusion Criteria:
  -  stage II or III colon cancer
  Exclusion Criteria:

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

Clinical trial: A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Summary: To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Detailed description: To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Eligibility: Inclusion Criteria:
  -  Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery)
  -  Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery)
  -  Patients who is between 20 and 80 years old at the time of obtaining informed consent
  -  Patients with performance status of 0 - 2
  -  Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
  -  Patients without severe dysfunction of renal, hepatic, or bone marrow function
  -  Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
  -  Patients who have given consent to participate in this clinical study by himself/herself or his/her family
  Exclusion Criteria:
  -  Patients in whom the bottom of tumor reaches the peritoneal reflection
  -  Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)
  -  Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
  -  Women who are currently pregnant or wish to be pregnant during this clinical study
  -  Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator

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

Clinical trial: COlon Cancer Laparoscopic or Open Resection

Summary: COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.

Detailed description: The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to participating centre, resection type and gender.
  Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an intention to treat basis.

Eligibility: Inclusion Criteria:
  -  Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
  -  Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
  -  Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
  -  Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
  -  BMI < 30 kg/m2
  -  Informed consent according to local requirements
  Exclusion Criteria:
  -  Carcinoma of the splenic flexure
  -  Carcinoma of the transverse colon
  -  Signs of acute intestinal obstruction
  -  More than one colon tumour
  -  Scheduled need for other synchronous colon surgery
  -  Synchronous surgery ofr other intra-abdominal organs
  -  Pre-operative indication of invasion of adjacent organs
  -  Pre-operative evidence of distant metastases
  -  Previous ipsilateral colon surgery
  -  Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
  -  Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
  -  Pregnancy

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

Clinical trial: Safety Study of PLX4032 in Patients With Solid Tumors

Summary: The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Detailed description: Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.
  Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.

Eligibility: Inclusion Criteria:
  -  Solid tumors confirmed histologically whose tumors are refractory to standard therapy, or for whom standard or curative therapy does not exist
  -  Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032
  -  Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be resolved prior to administration of PLX4032
  -  Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum) must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0 criteria) prior to the administration of PLX4032. All patients enrolled must provide archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation status by TaqMan assay
  -  ECOG performance status 0 or 1
  -  Life expectancy ≥ 3 months
  -  Adequate hematologic, hepatic, and renal function
  Exclusion Criteria:
  -  Brain metastases that are progressing or have been documented to be stable for less than 3 months, or for which systemic corticosteroids are required
  -  Investigational drug use within 28 days of the first dose of PLX4032
  -  Uncontrolled intercurrent illness
  -  Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption

Relevance to patient case: not relevant