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


N/A
20 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Gi-Shih Lien

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taipei Medical University WanFang Hospital

Authority:

Taiwan: Department of Health

Study ID:

99064

NCT ID:

NCT01371942

Start Date:

May 2010

Completion Date:

May 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer(CRC)
  • Colorectal Neoplasms

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