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NCT01104077 · ClinicalTrials.gov registry record
Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 277
- Enrollment target
NCT01104077: Completed study, sponsored by Columbia University.
NCT01104077 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 277 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104077 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 277 participants
- Enrollment target
Study Summary
This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN). The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and follow-up information from the Pancres Center database. The investigators will also conduct a chart review to collect information recorded by clinicians on each subject's family history of malignancy and personal history of malignancy. Results of this database and chart review will be incorporated into a datasheet in which all patient identifiers have been removed. The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history.
Primary Outcome
Extent of Family History: The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2008-11-17 |
| Est. Completion | 2021-04-27 |
What the finished NCT01104077 record still lists
NCT01104077 is an observational study that tracks outcomes without assigning an intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01104077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104077 about?
NCT01104077 is a clinical study titled "Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)". This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN). The investigators will be reviewing the demographic, clinical, radiologic, pa...
What is the current status of trial NCT01104077?
This trial is currently completed. The enrollment target is 277 participants. The study started on 2008-11-17. Estimated completion is 2021-04-27.
Who is sponsoring clinical trial NCT01104077?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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