NCT00582452

Brief Summary

The purpose of this study is to learn more about individual's with a family history of colon cancer and the process by which they may decide to undergo or not undergo prophylactic colectomy. This is a surgery to remove the colon in order to reduce risk of cancer (or of getting cancer again).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 10, 2009

Status Verified

December 1, 2009

Enrollment Period

5.1 years

First QC Date

December 21, 2007

Last Update Submit

December 9, 2009

Conditions

Colorectal Cancer

Keywords

HNPCCprophylactic colectomy

Outcome Measures

Primary Outcomes (1)

  • To assess levels of intention in prophylactic colectomy among individuals at increased familial risk of colorectal cancer and to identify distinctive decision types based on profiles of perceived pros and cons of prophylactic colectomy;

    12 months

Study Arms (2)

2

Affected patients who are at high risk for metachronous colorectal tumors due to mutation status.

Other: Telephone survey

1

Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status.

Other: Telephone survey

Interventions

Telephone surveyOTHER

Telephone survey

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status, and affected patients who are at high risk for metachronous colorectal tumors due to mutation status.

You may qualify if:

  • are from a family that has a known mismatch repair mutation; or
  • meet Amsterdam I or Amsterdam II criteria that spell out the family and personal cancer history characteristics associated with HNPCC
  • are considered at sufficiently high risk by their CRC specialty physician that prophylactic colectomy may be presented as an option (excluding FAP).
  • Amsterdam I Criteria
  • At least three relatives with a colorectal cancer and the following criteria:
  • One should be a first degree relative of the other two
  • At least two successive generations should be affected
  • At least one colorectal cancer should be diagnosed before the age of 50
  • Familial Adenomatous Polyposis (FAP) should be excluded in the colorectal cancer case(s), if any
  • Amsterdam II Criteria (also known as Revised Amsterdam Criteria
  • At least three relatives with an HNPCC-associated cancer (colorectal cancer, cancer of the endometrium, small bowel, ureter, or renal pelvis) \*:
  • One should be a first degree relative of the other two
  • At least two successive generations should be affected
  • At least one relative should be diagnosed before age 50
  • FAP should be excluded in the colorectal cancer case(s), if any \*NOTE: ovarian cancer will also be considered an HNPCCassociated cancer as per Lynch et al (NEJM 2003)

You may not qualify if:

  • non-English speaking
  • under the age of 18
  • are unable to give meaningful informed consent due to physical, psychiatric or cognitive disability
  • are from a family affected by FAP
  • have already undergone subtotal colectomy or total proctocolectomy
  • are in active treatment and/or less than six months post-surgery for cancer.
  • Have undergone genetic counseling and testing for HNPCC at MSKCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Karen Hurley, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

November 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 10, 2009

Record last verified: 2009-12

Locations

US(1)