Elizabeth Registry for Low Grade Ovarian Cancer

October 5, 2015 updated by: M.D. Anderson Cancer Center

The Elizabeth Registry for Low Grade Ovarian Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Registry will be an ongoing research registry that will include patients who have been diagnosed with low grade ovarian, primary peritoneal or fallopian tube or low malignant potential (LMP) ovarian, primary peritoneal or fallopian tube cancer.

In order to enroll in the Registry, you will be asked to complete a 65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors. This questionnaire will take about 1 hour to complete.

In addition, researchers will look at your medical record and pathology samples stored at M. D. Anderson to get information about your surgeries, treatments, disease course, and tumor grade. If your original surgery was not performed at M. D. Anderson, you may be asked to provide tumor specimens from that surgery before enrolling in the Registry.

You will be contacted annually by the Registry Coordinator to update your demographic and health information.

This is an investigational study. The Registry will eventually enroll both M. D. Anderson and non-M. D. Anderson patients. The number of registrants is unlimited because the Registry will be ongoing. This study is partially funded by a research grant from the Elizabeth Fund for the Study of Low Grade Ovarian Carcinoma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
National Research Registry Enrollment
Patient, living or deceased, with a pathologically-confirmed diagnosis of Ovarian Cancer.
Behavioral: Questionnaire
65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 30 Years
30 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
Time Frame: 30 Years
30 Years
Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
Time Frame: 30 Years
30 Years
Identify potential precursors of low grade and LMP ovarian cancer.
Time Frame: 30 Years
30 Years
Assess treatment patterns to guide management of these diseases.
Time Frame: 30 Years
30 Years
Collect quality of life and health outcomes data on these patients.
Time Frame: 30 Years
30 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane C. Bodurka, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2003-0359

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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