araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Gene Testing in Patients With Colon Cancer

Summary: RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.
  PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

Detailed description: OBJECTIVES:
  -  Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
  -  Determine the prognostic and predictive values for response to this therapy in these patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896
  -  Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor
  -  Surgical specimen blocks available, including tumor tissue and normal tissue

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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:
  -  none

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

Summary: RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant.
  PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.

Detailed description: PRIMARY OBJECTIVES:
  I. To evaluate the effects of lithium on functional and mucosal anatomic recovery in the small or large bowel of patients with acute GVHD.
  II. Functional recovery will be evaluated according to changes in clinical manifestations of gastrointestinal GVHD. III. Mucosal anatomic recovery will be evaluated by review of results from clinically indicated endoscopic evaluations.
  SECONDARY OBJECTIVES:
  I. To assess the tolerability of lithium administration in allogeneic hematopoietic cell transplant recipients.
  OUTLINE: Patients receive oral lithium carbonate once or twice daily. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility: Inclusion Criteria:
  -  Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes > 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
  -  Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
  -  All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB)
  Exclusion Criteria:
  -  Significant renal dysfunction (estimated creatinine clearance < 30 mL/min)
  -  Persistent or recurrent malignancy
  -  Secondary malignancy
  -  Patients who had autologous or syngeneic marrow transplantation
  -  Presence of any cause of intestinal symptoms or ulceration other than GVHD
  -  Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer

Summary: Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.

Detailed description: Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose of 6 mg will be given once a day.
  Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.
  Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose found in the phase I study is lower).
  Preoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by TME-surgery 7-8 weeks post RT.
  Sample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6 eligible patients per step. Phase II A total of 47 patients will be entered in this part of the study.

Eligibility: Inclusion Criteria:
  -  Histologically proven rectum cancer
  -  UICC TNM I-III
  -  WHO performance status 0-2
  -  Less than 10% weight loss the last 6 months
  -  No recent (< 3 months) severe cardiac disease
  -  Normal serum bilirubin and serum creatinin
  Exclusion Criteria:
  -  Concurrent chemotherapy with radiation
  -  History of prior pelvis radiotherapy
  -  Recent (<3 months) myocardial infarction
  -  Uncontrolled infectious disease
  -  Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer

Summary: RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.
  PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.
  Secondary
  -  Analyze differences in cognitive measures and MRI data in these patients.
  -  Correlate MRI measures with cognitive performance in these patients.
  OUTLINE: Patients undergo cognitive performance assessment and MRI.
  PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer
  -  Received chemotherapy and radiotherapy for colon cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

Summary: To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies

Detailed description: This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

Eligibility: Inclusion Criteria:
  1. The subject's written informed consent had to be obtained prior to inclusion.
  2. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
  3. Willing, able and competent to complete the entire procedure and to comply with study instructions
  4. Females of childbearing potential had to employ an adequate method of contraception
  Exclusion Criteria:
  1. Ileus
  2. Intestinal obstruction or perforation
  3. Toxic megacolon
  4. History of colonic resection
  5. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
  6. Congestive heart failure (NYHA III + IV)
  7. Acute life threatening cardiovascular disease
  8. Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
  9. Known moderate to severe renal insufficiency
  10. Severe renal failure
  11. Severe liver failure
  12. Known glucose 6 phosphatase dehydrogenase deficiency
  13. Known phenylketonuria
  14. Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
  15. Concurrent participation in an investigational drug study or participation within 30 days of study entry
  16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
  17. Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study

Summary: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum


Eligibility: Inclusion Criteria:
  -  Patients with metastatic cancer of colon or rectum

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Summary: The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility: Inclusion Criteria:
  -  Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
  -  Estimated life expectancy of more than 3 months
  -  ECOG performance status of 0 to 1 at study entry
  -  Adequate bone marrow function
  -  Adequate liver function
  -  Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
  -  Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
  -  Informed Consent
  Exclusion Criteria:
  -  Central nervous system (CNS) metastases or prior radiation for CNS metastases.
  -  Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
  -  Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
  -  Evidence of gastrointestinal bleeding
  -  Exposure to Cetuximab
  -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
  -  KRAS mutant Status
  -  Patients with serious toxicity to previous irinotecan-based chemotherapy
  -  Other serious illness or medical conditions

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Summary: Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
  Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility: Inclusion Criteria:
  -  Hystological diagnosis of breast cancer
  -  Availability of tumor tissue
  -  Availability to assess the response to Trastuzumab according to RECIST criteria
  -  Availability of clinical data
  Exclusion Criteria:
  -  Unavailability of tumor tissue
  -  Impossibility to assess the response to Trastuzumab according to RECIST criteria

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

Summary: This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.


Eligibility: Inclusion Criteria:
  -  metastatic colorectal cancer
  -  tumor with k-ras mutation
  Exclusion Criteria:
  -  More than 1 prior regimen for treatment of metastatic disease

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps

Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.
  PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.
  -  To determine the compliance rates in patients treated with these regimens.
  Secondary
  -  To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.
  -  To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.
  OUTLINE: Patients are randomized to 1 of 2 arms.
  -  Arm I: Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
  -  Arm II: Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
  Patients complete questionnaires about demographics, dietary vitamin D intake, personal history (e.g., ancestry, alcohol and tobacco intake, occupation, height, and weight), medical history (e.g., personal and family history of colorectal cancer and polyps), and ultraviolet radiation exposure.
  Blood samples are collected at baseline and at 6 months for correlative laboratory studies. Blood samples are analyzed for vitamin D levels by enzyme immunoassay. Patients also undergo assessment of skin pigmentation in sunprotected and sunexposed areas of skin by reflectance spectrometry at baseline.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenomatous polyp
  -  At least 1 adenoma
  -  Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago
  -  No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis)
  PATIENT CHARACTERISTICS:
  -  Total bilirubin normal
  -  AST and ALT ≤ 2.5 times upper limit of normal
  -  Creatinine normal
  -  Albumin ≥ 3.0 mg/dL
  -  Baseline serum calcium level normal
  -  Not pregnant
  -  No history of thyroid disease
  -  No history of renal stones
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No other concurrent vitamin D intake

Relevance to patient case: not relevant