Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation (BetrnetRF)
This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Collaborator:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01568723
First received: March 29, 2012
Last updated: November 6, 2012
Last verified: November 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 29, 2012 | ||||||||
| Last Updated Date | November 6, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | August 2017 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Response to therapy [ Time Frame: one year post ablation ] [ Designated as safety issue: No ] evaulation will be made at 3 month intervals for one year post ablation |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01568723 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 | Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation | ||||||||
| Official Title ICMJE | Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus | ||||||||
| Brief Summary | The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus. |
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| Detailed Description | This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus. |
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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: biopsy samples, serum, plasma, buffycoat, cytology brushings |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants must have biopsy proven Barret's esophgus with evidence of specialized intestinal epithelium with high grade dysplasia or early intramucosal carcinoma (mEAC) on histology (confirmed by two pathologists). Patients must have a BE length ≥ 2 cm and ≤ 8 cm. |
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| Condition ICMJE | Barrett's Esophagus | ||||||||
| Intervention ICMJE | Genetic: response to therapy
evaluate specific markers for response to therapy at 3 month intervals |
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| Study Group/Cohort (s) | Radiofrequency ablation
participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)
Intervention: Genetic: response to therapy |
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| 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 | 160 | ||||||||
| Estimated Completion Date | August 2018 | ||||||||
| Estimated Primary Completion Date | August 2017 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01568723 | ||||||||
| Other Study ID Numbers ICMJE | 11-006510, U54CA163004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kenneth K. Wang, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | November 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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