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

Clinical trial: Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Summary: This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.


Eligibility: Inclusion Criteria:
  -  Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
  -  Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
  -  An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
  -  The primary cancer was a Duke's A or B1.
  -  Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
  Exclusion Criteria:
  -  Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
  -  Patients cannot have concurrent malignancies at study entry.
  -  Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.

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

Clinical trial: Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

Summary: The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
  -  Metastatic colorectal carcinoma
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
  -  Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
  -  Unidimensionally measurable disease
  -  Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
  -  At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
  -  Adequate hematologic, renal and hepatic function
  Exclusion Criteria:
  -  Symptomatic brain metastases requiring treatment
  -  History or evidence of interstitial pneumonitis or pulmonary fibrosis
  -  Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
  -  Prior epidermal growth factor receptor (EGFr) targeting therapies
  -  Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.

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

Clinical trial: Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

Summary: This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.


Eligibility: Inclusion Criteria:
  -  Measurable metastatic carcinoma of the colon or rectum.
  -  1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor [EGFR] targeted therapy)
  -  Chest/abdomen/pelvis scans every 6-12 weeks
  -  ECOG 0-2
  -  Hemoglobin (Hgb) > or = 8g/dl within 7 days prior to enrollment
  -  Age > or = to 18 years of age
  Exclusion Criteria:
  -  Cumulative weekly blood draws exceeding 150mL/week
  -  Brain metastasis
  -  Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
  -  Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device

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

Clinical trial: Implementation of a New Strategy to Identify HNPCC Patients

Summary: The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.

Detailed description: The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.

Eligibility: Inclusion Criteria:
  -  Colorectal cancer before the age of 50 years
  -  Second colorectal cancer at any age
  -  Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis
  -  Adenoma with high grade dysplasia diagnosed before the age of 40 years

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

Clinical trial: A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Summary: The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Detailed description: The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Eligibility: Inclusion Criteria:
  1. Histologically proven colorectal carcinoma
  2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
  3. T3 or deeper lesion without involvement of other organs
  4. Without multiple lesion other than carcinoma in situ
  5. Cancer classified as N0-2 and M0, according to the TNM classification system
  6. Tumor size < 8 cm
  7. No bowel obstruction
  8. Age 20 < and > 75 years
  9. Sufficient organ function
  10. No history of gastrointestinal surgery
  11. No history of chemotherapy or radiotherapy
  12. Provided written informed consent
  Exclusion Criteria:
  1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
  3. Pregnant or lactating women
  4. Severe mental disease
  5. Continuous systemic steroid therapy

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

Clinical trial: Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin

Summary: To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Detailed description: Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.

Eligibility: Inclusion Criteria:
  -  All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
  -  Normal or non-diagnostic OGD and colonoscopy
  -  Informed consent
  -  Patients presented with shock will be resuscitated for urgent endoscopy
  Exclusion Criteria:
  -  Patients remained in shock despite resuscitation.
  -  Moribund patients
  -  Terminal malignancy
  -  Presence of pacemaker or ICD
  -  Suspected or confirmed intestinal obstruction
  -  Swallowing difficulties
  -  Renal failure that preclude angiographic examination
  -  Pregnancy
  -  Age <18
  -  Refused consent

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

Clinical trial: Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

Summary: Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.
  Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.
  After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.
  The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.


Eligibility: Inclusion Criteria:
  -  Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  -  Inoperable metastatic disease
  -  Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
  -  Presence of at least 1 bi-dimensionally measurable index lesion
  Exclusion Criteria:
  -  Previous irinotecan-based chemotherapy
  -  Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
  -  Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
  -  Brain metastasis

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

Clinical trial: Colorectal Cancer Screening Intervention in UWPN Clinics

Summary: The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.

Detailed description: Colorectal cancer is the second leading cause of cancer death in the United States. Colorectal cancer screening is widely recommended, but generally under-utilized. Previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. Barriers to screening include patient and provider-related factors. An innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services.
  In this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. This network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. In the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. This module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. The information provided by this module will be supplemented by the services of a cancer prevention specialist. This person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests.
  Outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. If successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.

Eligibility: Inclusion Criteria:
  -  Age 50 years and over, enrolled for medical care in the UWPN clinics
  Exclusion Criteria:
  -  Primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures

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

Clinical trial: Quality Initiative in Rectal Cancer (QIRC) Trial

Summary: The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.

Detailed description: Approximately 5000 Canadians are annually diagnosed with rectal cancer. For patients undergoing rectal cancer surgery two unfortunate outcomes are permanent colostomy and local tumor recurrence. Research demonstrates that in Ontario, Canada and other parts of the world the standard of care for rectal cancer surgery leaves room for improvement.
  This is a multi-center trial that will test if a set of interventions designed to positively influence surgeon practice, titled the Quality Initiative in Rectal Cancer (QIRC) strategy, can improve rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. Secondary outcomes to be assessed include sexual, bowel, and bladder function, and quality of life. The QIRC strategy consists of a workshop to discuss quality issues in rectal cancer, operative demonstration to demonstrate optimal surgical techniques, the use of opinion leaders, and a postoperative questionnaire designed to prompt surgeons to re-examine their key operative steps. The QIRC strategy is largely designed to teach total mesorectal excision, a new gold standard for rectal cancer surgery that has been shown in non-randomized studies to lower patient rates of permanent colostomy and local tumour recurrence.
  Sixteen hospitals across the province of Ontario were allocated by cluster randomization to the QIRC strategy (experimental arm) versus minimal intervention (control arm). All hospitals are high-volume centres - an annual rectal cancer procedure volume of 15 or greater. Hospitals in the control arm represent the normal practice environment. Approximately 700 patients will be assessed. In addition to measuring rates of permanent colostomy and local recurrence of tumour, the study will examine bowel, bladder and sexual function, and overall quality of life among patients.
  A positive trial – better results in hospitals that receive the intervention – may suggest that to effectively influence surgeon practice, resource intense approaches are necessary along with active buy-in from the surgical community.

Eligibility: Inclusion Criteria:
  Hospital inclusion criteria:
  1. An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.
  Patient inclusion criteria:
  1. Consecutive patients at each participating site who underwent major rectal cancer surgery.
  2. Tumor located within 15 cm of anal verge by rigid sigmoidoscopy, or, at or below the level of the sacral promontory at the time of surgery.
  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: A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Summary: To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.

Detailed description: Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
  UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.
  5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.
  Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Eligibility: Inclusion Criteria:
  1. Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
  2. Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
  3. Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
  4. No synchronous colorectal cancer which invade muscularis propria or deeper.
  5. Tumor resection with D2 or D3 lymph node dissection was performed.
  6. Pathological determination of curability of tumor resection is cur A.
  7. Age at registration is above 20 and below 75 years old.
  8. ECOG Performance status is 0 or 1.
  9. No prior chemotherapy or radiation therapy.
  10. Intake of normal diet and oral drugs is possible.
  11. Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
  12. Adjuvant chemotherapy can be started within 9 weeks after surgery.
  13. Written informed consent is taken.
  Exclusion Criteria:
  1. Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
  2. Severe postoperative complications which do not resolve until registration.
  3. There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
  4. Pregnant or breast-feeding woman.
  5. Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
  6. Judged to be inappropriate to register.

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

Clinical trial: Comparison of Fecal Ribonucleic Acid (RNA) Test With Fecal Occult Blood Test (FOBT) for Detecting Colorectal Cancer and Adenoma

Summary: Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening, which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there is a need to develop a novel method to improve sensitivity. The investigators reported that Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal RNA test with FOBT for detecting colorectal cancer and adenoma.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colorectal cancer or adenoma
  -  Subjects with no abnormal findings of colon

Relevance to patient case: not relevant