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

Clinical trial: Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Summary: The aim of the investigators' randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colorectal carcinoma.

Detailed description: Since the introduction of laparoscopic cholecystectomy in 1987, laparoscopic surgery has been attempted and applied to many surgical operations. Surgeons in Hong Kong began to perform laparoscopic surgery for colorectal carcinoma in early 1992. Early reports of laparoscopic surgery for colorectal carcinoma from Hong Kong and worldwide suggested better short-term clinical outcomes when compared with open surgery, but there were concerns over port site metastases and adequacy of long-term oncological clearance. Besides, only a few randomized trials thus far have compared laparoscopic-assisted and open surgery for rectal carcinoma.
  The aim of our randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colonic and rectal carcinoma.
  Patients will undergo different types of surgery according to the location of the tumors: right or extended right hemicolectomy for cecal, ascending colon, or hepatic flexure tumors; left hemicolectomy for descending colon tumors; sigmoid colectomy for sigmoid colon tumors; anterior resection for rectosigmoid or upper rectal tumors; low anterior resection with total mesorectal excision for mid- and low rectal tumors; abdominoperineal resection for very low rectal tumors. Patients will be randomly allocated to laparoscopic assisted or conventional open surgery.
  Short-term clinical outcome and long-term survival data will be prospectively recorded and compared between the two treatment arms.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed to have colorectal carcinoma at all locations except transverse colon
  -  Informed consent available
  Exclusion Criteria:
  -  Patients with tumor >6 cm in size, or with tumor infiltration to adjacent organs on imagings
  -  Patients with previous abdominal surgery near the region of the colorectal surgery
  -  Patients with intestinal obstruction or perforation
  -  Patients with recurrent disease
  -  Patients with synchronous colorectal carcinoma

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

Clinical trial: DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

Summary: The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Detailed description: Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.
  The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.
  The aim of the present study is to determine whether
  1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
  2. Whether disease-specific survival or overall survival is improved by addition of zalutumumab
  3. Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
  4. Acute and late toxicity to the treatment.

Eligibility: Inclusion Criteria:
  -  Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
  -  Curative intent and no prior treatment
  -  Age > 18 years
  -  WHO performance 0-2 (incl.)
  -  No prior treatment with EGFr-I
  -  Informed consent according to local guidelines and national law
  -  The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
  -  Fertile women must use contraceptive devices (IUD or oral contraceptives)
  Exclusion Criteria:
  -  Rhinopharynx or carcinomas of unknown origin
  -  Distal metastases
  -  Other malignant diseases (prior or current) except from planocellular skin 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: Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
  PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

Detailed description: OBJECTIVES:
  -  Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
  OUTLINE: This is a pilot study.
  Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
  Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
  After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of epithelial solid tumors of any of the following sites or types:
  -  Lung (closed to accrual as of 4/2/2009)
  -  Renal
  -  Prostate
  -  Breast (closed to accrual as of 4/2/2009)
  -  Sarcoma (closed to accrual as of 4/2/2009)
  -  Colon (closed to accrual as of 4/2/2009)
  -  Liver(closed to accrual as of 4/2/2009)
  -  Pancreatic (closed to accrual as of 4/2/2009)
  -  Bone (closed to accrual as of 4/2/2009)
  -  Head and neck (closed to accrual as of 4/2/2009)
  -  Melanoma (closed to accrual as of 4/2/2009)
  -  Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
  -  Advanced or metastatic disease
  -  Ineligible for or unwilling to undergo surgical resection
  -  Eligible for cryotherapy but not expected to be cured by cryotherapy alone
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  Creatinine < 2.5 mg/dL
  -  Platelet count >75,000/mm³
  -  INR< 1.5
  -  No known HIV positivity
  -  No active, uncontrolled infection
  -  Not pregnant
  -  Negative pregnancy test
  -  Women of childbearing potential must practice adequate contraception
  -  No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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 FOLFOX Combination

Summary: A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
  2. WHO performance status 0-1
  3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques
  Exclusion Criteria:
  1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
  2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
  3. prior unanticipated severe reaction to oxaliplatin

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 Irinotecan, 5-Fluorouracil and Leucovorin Combination

Summary: A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Confirmed metastatic colorectal adenocarcinoma
  2. Not amenable to surgery or radiation therapy
  3. Eligible for first or second line chemotherapy
  Exclusion Criteria:
  1. Brain metastases or spinal compression
  2. Last prior chemotherapy discontinued within 4 weeks before start
  3. Last dose radiotherapy within 4 weeks of start

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

Clinical trial: Metabolomics-Based Detection of Colorectal Cancer

Summary: The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.

Detailed description: In this study, metabolite profiling analysis will be carried out on colon cancer patients at the time of diagnosis and during the course of treatment, using patient tissue and serum samples. Samples of serum (1 ml) and tissue specimens (50 mg each) from colorectal cancer patients (stages I-IV) and serum samples from an equal number of age and gender-matched healthy controls will be obtained under identical (8-hour overnight fasting) conditions. Metabolic profiles will be identified using the NMR and MS instruments located in Purdue's on-campus NMR and MS facilities. Multivariate statistical analyses will be used to monitor changing metabolite profiles that indicate changes in disease status. We anticipate that putative biomarkers will be easier to identify in the cancerous tissue, and the concentrations of these metabolites will then be quantified in the patients' serum, that ultimately would allow for easier detection of colon cancer.

Eligibility: Inclusion Criteria:
  -  Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
  -  Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
  -  Subjects must be ≥ 18 years of age.
  -  Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
  -  For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema.
  -  Subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
  -  Female patients known to be pregnant are not eligible for this protocol.
  -  Subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing
  Exclusion Criteria:
  -  Presence of an invasive cancer other than colorectal cancer is an exclusion criterion

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

Clinical trial: Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Summary: The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

Detailed description: The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Eligibility: Inclusion Criteria:
  -  Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
  Exclusion Criteria:
  -  ECOG Performance Status >=2
  -  Age<20
  -  Any organ dysfunction
  -  Ileus
  -  Preoperative infectious disease
  -  Antibiotic administration before surgery
  -  Steroid administration before surgery
  -  Neo-adjuvant radiation and/or chemo therapy
  -  Severe diabetes mellitus
  -  Pregnancy/lactational woman
  -  Severe allergy

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

Clinical trial: Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients

Summary: Among women with HNPCC, this study will assess:
  1. Knowledge of screening recommendations for endometrial and ovarian cancers.
  2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
  3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.
  4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
  5. Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
  6. Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.

Detailed description: Women who are at risk for HNPCC will be recruited to participate in this pilot study.
  Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.
  Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.

Eligibility: Inclusion Criteria:
  1. Being female
  2. Being 25 years of age or older
  3. Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC
  Exclusion Criteria:
  1. Persons who have tested negative for a known HNPCC-predisposing mutation in their family
  2. Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
  3. Being younger than 25 years old
  4. Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.

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

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: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid

Summary: The purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.

Detailed description: Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument.

Eligibility: Inclusion Criteria:
  -  English-speaking
  -  Scheduled to see an internal medicine provider
  -  No recent colorectal cancer screening
  Exclusion Criteria:
  -  Personal history of colorectal cancer
  -  Family history of colorectal cancer
  -  Blood seen in stools within last month
  -  Obvious cognitive or physical impairment that would prevent participation

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

Clinical trial: Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

Summary: RATIONALE: Collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease.
  PURPOSE: This clinical trial is studying the European Organization of Research for the Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.

Detailed description: OBJECTIVES:
  -  To test the reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29) in an international sample of patients with colorectal cancer.
  OUTLINE: This is a multicenter study. Patients are stratified into predetermined clinically distinct groups (colon cancer after surgery vs colon cancer undergoing adjuvant chemotherapy vs rectal cancer undergoing neoadjuvant radiotherapy vs rectal cancer after anterior resection with temporary stoma vs rectal cancer after abdominoperineal excision of rectum vs colorectal cancer undergoing palliative chemotherapy).
  Quality-of-life data is collected alongside standard outcomes in patients undergoing treatment for colorectal cancer. Patients complete the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30), the revised colorectal cancer module (QLQ-CR29), case report forms for clinical and sociodemographic data, and a debriefing questionnaire at different time points before, during, and after treatment. Some patients complete more sets of the same questionnaire at later time points to assess sensitivity to change over time and test-retest reliability. Reliability, and clinical and psychometric validity of the questionnaires are assessed by correlation analyses, exploration of known group comparisons, and responsiveness to clinical changes.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the colon or rectum
  -  No brain metastases or intracranial tumor extension with cognitive impairment
  PATIENT CHARACTERISTICS:
  -  No limit on performance status
  -  Able to understand the language of the questionnaire
  -  No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  -  No other concurrent malignancies except basal cell carcinoma of the skin
  PRIOR CONCURRENT THERAPY:
  -  No prior participation in this study (in a different subgroup)
  -  No concurrent participation in other quality of life studies that might interfere with this 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: Tissue and Serum Collection From Colorectal Cancer Patients

Summary: To establish a serum and tissue bank with specimens form patients with colorectal cancer, for subsequent immunological and biochemical analysis.


Eligibility: Inclusion Criteria:
  -  Patients must be undergoing surgery for resection of their primary tumor, resection of hepatic metastases, or hepatic artery catheter and pump implant for unresectable hepatic metastases.
  -  For and tumor specimen removed at surgery ,the lesion must be large enough to allow for routine pathological analysis, with excision from residual otherwise discarded material for the tumor bank.
  Exclusion Criteria:

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

Clinical trial: Identification of New Colorectal Cancer Genes

Summary: The purpose of this study is to define new genes for family risks of developing colon cancer.

Detailed description: Colorectal cancer is one of the most significant causes of cancer morbidity and mortality in the United States. In 1997, approximately 130,000 men and woman were diagnosed with colorectal cancer (fourth most common cancer site) and approximately 55,000 died of this disease (second most common cause of cancer deaths); (Cancer Facts & Figures, 1997).
  Genetic factors clearly contribute to the etiology of colorectal cancer. Because there is evidence to suggest genetically determined susceptibility to colorectal cancer exists in a proportion of newly diagnosed cases each year, we are conducting a study to identify new genes that are associated with an increased susceptibility to familial colorectal cancer by analysis of families with a clustering of colorectal cancers.

Eligibility: Inclusion Criteria:
  -  Age 18 years or greater
  -  Able to provide informed consent
  -  Any family in which a minimum of two first-degree relatives either are, or have previously been, affected with primary colorectalcancer. These "minimum inclusion criteria" must be met within three generations of the proband or kindreds in which colorectal cancer and lymphoma or renal cell cancer are present or in kindreds in which lymphoma alone or lymphoma and renal cell cancer are present
  Exclusion Criteria:
  -  Age less than 18 years
  -  Family not at increased risk for familial colorectal cancer (see Section 4.1)
  -  Family with a hereditary polyposis syndrome (e.g. classic FAP)
  -  Not able to provide informed consent

Relevance to patient case: not relevant