Development of Early Detection Signs for Gastrointestinal Cancer
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 3, 2008 | ||||||||
| Last Updated Date | June 13, 2012 | ||||||||
| Start Date ICMJE | September 2003 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers. [ Time Frame: 1 N/A ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00633334 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The second goal is to evaluate using novel proteomic, CellomicTM, and genomic techniques the serum and peripheral blood lymphocytes of these patients for protein, cellular changes and genetic markers that correlate with the presence of cancer. [ Time Frame: 1 N/A ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Development of Early Detection Signs for Gastrointestinal Cancer | ||||||||
| Official Title ICMJE | Investigation of the Immune Response to Gastrointestinal Tumors and Development of Novel Biomarkers for the Presence of Gastrointestinal Cancer | ||||||||
| Brief Summary | Therapies involving the immune system have already shown great promise in early clinical trials for the treatment of renal cell carcinoma and melanoma. One of the great challenges now facing this field is to extend these findings to other cancers. Little is currently understood about the nature of the immune response to more common gastrointestinal cancers. The first goal of this proposal is to collect blood and tissue samples from patients with early or late stage gastrointestinal cancers. These samples will be evaluated to better understand the immune response to these two cancers. The second goal of this proposal is to evaluate the specimens of these patients for changes and genetic markers that correlate with the presence of cancer. The information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer. |
||||||||
| Detailed Description | The first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers. These samples will be evaluated in a variety of immunological assays to better understand the immune response to these two cancers. The second goal of this proposal is to evaluate using novel proteomic, cellomic, and genomic techniques the serum and peripheral blood lymphocytes of these patients for protein, cellular changes and genetic markers that correlate with the presence of cancer. The information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: peripheral blood portions of tumor tumor draining lymph nodes |
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Potential research subjects are first identified by their primary doctor/clinical team. The research project will be discussed and mutually agreed upon between the subject and his/her caregiver before the research team will contact the subject. Other subjects are referred in specifically for possible participation in a particular study which they or their physician are aware of based on publications which list clinical trials at UPMCHS. |
||||||||
| Condition ICMJE | GI Cancer | ||||||||
| Intervention ICMJE | Other: Specimen bank
Patients will be asked to provide approximately 60-120 cc (4-8 tablespoons) of peripheral blood. Select patients who undergo surgical resection of their tumor will be asked to provide portions of the tumor and tumor draining lymph nodes for further analysis. In addition patients undergoing surgical resection may be asked to provide additional peripheral blood samples at time of routine follow-up (at least 4-6 weeks after initial blood draw and between subsequent draws). |
||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00633334 | ||||||||
| Other Study ID Numbers ICMJE | 02-077 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | June 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||