Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials
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| First Received Date ICMJE | June 15, 2007 | ||||||||
| Last Updated Date | April 23, 2013 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00487513 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials | ||||||||
| Official Title ICMJE | Procurement of Follicular B Cell Lymphoma Cells From Blood, Tissue or Malignant Effusion for the Purpose of Possible Use in Future Clinical Trials: A Minimal Risk Protocol | ||||||||
| Brief Summary | In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting samples from people with this diagnosis. We then hope to make a vaccine from this tissue to help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank indefinitely. |
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| Detailed Description | - The following tests and procedures will be performed: Approximately 50cc of peripheral blood will be drawn and stored in the tissue bank; patients who have follicular lymphoma cells circulating in the blood will have about 40cc's of blood drawn and stored for processing; patients undergoing a lymph node biopsy will have samples of the biopsy stored; patients having fluid drained from the abdomen or from around the lung will have some of their fluid saved to cell collection and processing; patients undergoing a bone marrow biopsy will have some of the sample stored for cell collection and processing. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole Blood Lymph node biopsy Drainage of an effusion Bone marrow biopsy |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants are selected because they have Non-Hodgkin's lymphoma. |
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| Condition ICMJE | Non-Hodgkin's Lymphoma | ||||||||
| Intervention ICMJE | Procedure: Procurement of Follicular B Cell Lymphoma Cells
Participants will undergo the following procedure(s) that are appropriate for collecting their tissue: Blood collection, lymph node biopsy, drainage of an effusion, or bone marrow biopsy |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00487513 | ||||||||
| Other Study ID Numbers ICMJE | 06-276 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eric Jacobsen, MD, Dana-Farber Cancer Institute | ||||||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Dana-Farber Cancer Institute | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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