Mutational Profiling in Colorectal Tumors to Determine Its Role in the Diagnosis, Prognostic Significance and Their Impact in Clinical Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01371942
First received: June 10, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

The aim of this study is to investigate mutational changes occurring in colorectal tumors, from benign polyps, malignant cancer and metastatic tumors. The investigators also plan to establish the clinical correlation, emphasizing on aspects such as the diagnosis and prognosis of disease and the specific treatment outcome. For the purpose, the investigators plan to obtain specimens from patients with colorectal tumors to extract DNA material. The specimens include tissues from either primary (mostly endoscopic biopsies specimens) or metastatic tumors (obtained from sonogram or other imaging modalities guided biopsy), as well as other humors including blood (for serum), malignant ascites, pleural effusions or other body fluids that could be related to CRCs. These patients would receive detailed explanations with regard to the investigations before signing IRB consent. At the initial stage, Wanfang Medical Center would be the only medical institution where endoscopic specimens would be collected. The project would eventually be extended to the Taipei Medical University Hospital and Shuan-Ho Hospital.


Condition
Colorectal Cancer

Study Type: Observational
Official Title: Mutational Profiling in Colorectal Tumors to Determine Its Role in the Diagnosis, Prognostic Significance and Their Impact in Clinical Management

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Detailed Description:

The following are items corresponding to the critical tasks of the project.

  1. Collect, annotate, and store fresh endoscopic specimens of suspicious abnormal tissue (premalignant lesions and primary tumors for genetic mutational investigation;
  2. Collect, annotate, and store fresh specimens from metastatic lesions (e.g.: hepatic metastatic tumors), under sonographic or other imaging modalities guided biopsy procedures;
  3. Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with colorectal tumor;
  4. Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol;
  5. To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies;
  6. To evaluate genomic and biochemical alterations in colorectal tumors.
  7. To test the effect of small molecule inhibitors on the activation of wild-type and mutant genetic alterations and/or other potential molecular targets.
  8. To correlate tumor genotype and signaling abnormalities with clinical response to genetic alterations and/or other potential molecular targets inhibitors
  9. Analysis of laboratory findings in relationship to patient demographics and clinical course.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Colorectal cancer patients

Criteria

Inclusion Criteria:

  • Patients must have been noted with a colonic tumor (benign polyps or colorectal cancer) on colonoscopy. Patients with lesions located other than the primary tumor (metastatic lesions) such as liver metastasis, enlarged lymph nodes suspicious of metastasis, malignant pleural effusion, ascites, etc. are also enrolled.
  • Age 20
  • Signed consent

Exclusion Criteria:

  • Known HIV infection
  • Known to have bleeding tendency, precluding for biopsy
  • Any other clinical conditions, which, in the opinion of the principal investigator, would not allow completion of this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371942

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Gi-Shih Lien Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Gi-Shih Lien, Department of Gastroenterology, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01371942     History of Changes
Other Study ID Numbers: 99064
Study First Received: June 10, 2011
Last Updated: June 10, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Colorectal cancer(CRC)

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014