NCT00510796

Brief Summary

Primary Objectives: To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer. To measure patient satisfaction for the combined procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2002

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

March 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

13.8 years

First QC Date

July 31, 2007

Last Update Submit

February 15, 2016

Conditions

Keywords

Hereditary Non-Polyposis Colon CancerColon CancerEndometrial CancerCancer ScreeningInterviewHNPCC

Outcome Measures

Primary Outcomes (1)

  • Feasibility to perform both colon and endometrial cancer screening at the time of colonoscopy in women at high risk for colon and endometrial cancer.

    8 Years

Study Arms (1)

High Risk Group

Colon and/or Endometrial Cancer

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

Interview regarding perception of pain and the benefits and barriers to the combined screening.

Also known as: Survey
High Risk Group

Eligibility Criteria

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

UT MDACC Female patients determined to be in a high risk group for either colon and/or endometrial cancer.

You may qualify if:

  • \) Women with medical indications for colonoscopy and endometrial biopsy.

You may not qualify if:

  • \) Must be 18 years of age and older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms, Hereditary NonpolyposisEndometrial Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Karen H. Lu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 2, 2007

Study Start

March 1, 2002

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations