Pancreatic CancerNCT01104077
Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)
An observational study of Pancreatic Cancer and Neoplasm, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Neoplasm
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2008to 27 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen at Columbia University Medical Center's Pancreas Center who have been diagnosed with intraductal papillary mucinous neoplasm, a cystic neoplasm of the pancreatic duct that has malignant potential.
Who may be able to join
- Tissue-confirmed diagnosis of intraductal papillary mucinous neoplasm or imaging suspicious for IPMN
- Seen in consultation for IPMN at Columbia-Presbyterian Medical Center between 2002 and 2008
Who cannot join
- Not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Family and Personal History of Pancreatic and Other Malignancies in Patients With Intraductal Papillary Mucinous Neoplasms
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.
Read the detailed description
Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is increasingly being identified in medical practice, including during the screening of individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of pancreatic cancers are familial. In comparison, there has been little research into the importance of genetic risk in IPMN incidence. The investigators will perform a retrospective chart review of patients with IPMN who were evaluated for surgical intervention at our tertiary referral center. The investigators are interested in determining the proportion of IPMN patients with a family history of pancreatic and other cancers. In addition, the investigators will assess if familial cancer risk is associated with increased risk for malignant IPMN and recurrence, relative to those patients without an inherited predisposition.
- Conditions
- Pancreatic Cancer, Neoplasm
- Keywords
- Pancreatic Cancer, Family History, Pre-cancerous lesion, Intraductal Papillary Mucinous Neoplasm (IPMN), Intraductal Papillary Mucinous Neoplasm
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of IPMN patients with relatives with pancreatic cancer or IPMN
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.
Measured: 20 years
Secondary outcomes (1)
Percentage of IPMN patients exhibiting higher malignant potential or recurrence following surgical resection
Characteristics of IPMN patients with Family History: 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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study start17 Nov 2008
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy K Chung, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104077
- Sponsor's protocol ID
- AAAD6106
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2010
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family and Personal History of Pancreatic and Other Malignancies in Patients With Intraductal Papillary Mucinous Neoplasms
- ClinicalTrials.gov ID
- NCT01104077
- Acronym / sponsor ID
- AAAD6106
- Conditions
- Pancreatic Cancer, Neoplasm
- Keywords
- Pancreatic Cancer, Family History, Pre-cancerous lesion, Intraductal Papillary Mucinous Neoplasm (IPMN), Intraductal Papillary Mucinous Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is increasingly being identified in medical practice, including during the screening of individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of pancreatic cancers are familial. In comparison, there has been little research into the importance of genetic risk in IPMN incidence. The investigators will perform a retrospective chart review of patients with IPMN who were evaluated for surgical intervention at our tertiary referral center. The investigators are interested in determining the proportion of IPMN patients with a family history of pancreatic and other cancers. In addition, the investigators will assess if familial cancer risk is associated with increased risk for malignant IPMN and recurrence, relative to those patients without an inherited predisposition.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen at Columbia University Medical Center's Pancreas Center who have been diagnosed with intraductal papillary mucinous neoplasm, a cystic neoplasm of the pancreatic duct that has malignant potential.
Key inclusion criteria (2 listed)
- Tissue-confirmed diagnosis of intraductal papillary mucinous neoplasm or imaging suspicious for IPMN
- Seen in consultation for IPMN at Columbia-Presbyterian Medical Center between 2002 and 2008
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of IPMN patients with relatives with pancreatic cancer or IPMN
Time frame: 20 years
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.
1 secondary outcome
Percentage of IPMN patients exhibiting higher malignant potential or recurrence following surgical resection
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy K Chung, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Neoplasm, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of IPMN patients with relatives with pancreatic cancer or IPMN (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.