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

June 10, 2011 updated by: Taipei Medical University WanFang Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University - WanFang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Colorectal cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University WanFang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gi-Shih Lien, Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 99064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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