NCT00345709

Brief Summary

Long-Term Objectives:

  • To establish an ongoing national research registry of epidemiologic, clinical and pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients in UTMDACC's Department of Gynecologic Oncology for research purposes.
  • To create a bank of low grade and LMP ovarian cancer tumor blocks for study of the molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP tumors and high grade ovarian cancer.
  • To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
  • To identify potential precursors of low grade and LMP ovarian cancer.
  • To assess treatment patterns to guide management of these diseases.
  • To collect quality of life and health outcomes data on these patients.
  • To achieve a fundamental understanding of low grade and LMP ovarian cancer that will inform prevention and screening efforts, motivate development of improved treatments and eventually result in a cure. The short-term objectives are:
  • To detail procedures for potential registrant identification and recruitment.
  • To create a demographic and health history questionnaire for potential registrants.
  • To begin aggregating low grade and low malignant potential ovarian tumor blocks.
  • To specify a timeline for the development of all other aspects of the Registry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

11.1 years

First QC Date

June 27, 2006

Last Update Submit

October 5, 2015

Conditions

Ovarian Cancer

Keywords

Ovarian CancerPeritoneal CancerFallopian Tube CancerElizabeth RegistryQuestionnaireRegistrySurvey

Outcome Measures

Primary Outcomes (1)

  • Establish an ongoing national research registry of epidemiologic, clinical and pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients in UTMDACC's Department of Gynecologic Oncology for research purposes.

    30 Years

Secondary Outcomes (5)

  • Create a bank of low grade and LMP ovarian cancer tumor blocks for study of the molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP tumors and high grade ovarian cancer.

    30 Years

  • Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.

    30 Years

  • Identify potential precursors of low grade and LMP ovarian cancer.

    30 Years

  • Assess treatment patterns to guide management of these diseases.

    30 Years

  • Collect quality of life and health outcomes data on these patients.

    30 Years

Study Arms (1)

National Research Registry Enrollment

Patient, living or deceased, with a pathologically-confirmed diagnosis of Ovarian Cancer.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.

Also known as: Survey
National Research Registry Enrollment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

M.D. Anderson Cancer Center Patient, living or deceased, with a pathologically-confirmed diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma.

You may qualify if:

  • UTMDACC patient, living or deceased, with a pathologically-confirmed diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma.
  • Able to speak and read English (for patients who are living).
  • Residence in the United States, both at time of original diagnosis and at time of accession to the Registry.

You may not qualify if:

  • UTMDACC patients, living or deceased, whose diagnosis of either low grade ovarian carcinoma or LMP ovarian carcinoma has not been confirmed pathologically.
  • Any type of ovarian cancer other than low grade or LMP ovarian carcinoma.
  • Unable to speak and read English (for patients who are living).
  • Residence outside the United States, either at time of original diagnosis or at time of accession to the Registry.

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

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube 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

  • Diane C. Bodurka, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

September 1, 2003

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

US(1)