Ovarian CancerNCT00345709
Elizabeth Registry for Low Grade Ovarian Cancer
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Oct 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Questionnaire
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Elizabeth Registry, Questionnaire, Registry, Survey
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.
| Study group | Role | What they receive |
|---|---|---|
| National Research Registry Enrollment | Patient, living or deceased, with a pathologically-confirmed diagnosis of Ovarian Cancer. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 Years
Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
Measured: 30 Years
Identify potential precursors of low grade and LMP ovarian cancer.
Measured: 30 Years
Assess treatment patterns to guide management of these diseases.
Measured: 30 Years
Collect quality of life and health outcomes data on these patients.
Measured: 30 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startSep 2003
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane C. Bodurka, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345709
- Sponsor's protocol ID
- 2003-0359
- Status last verified
- Oct 2015
- First submitted
- 27 Jun 2006
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Elizabeth Registry for Low Grade Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00345709
- Acronym / sponsor ID
- 2003-0359
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Elizabeth Registry, Questionnaire, Registry, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jun 2006 (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.
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.
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 design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| National Research Registry Enrollment | – | Behavioral: QuestionnairePatient, living or deceased, with a pathologically-confirmed diagnosis of Ovarian Cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Survey65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors. | Behavioural | National Research Registry Enrollment |
Primary outcome
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
5 secondary outcomes
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
Specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients.
Time frame: 30 Years
Identify potential precursors of low grade and LMP ovarian cancer.
Time frame: 30 Years
Assess treatment patterns to guide management of these diseases.
Time frame: 30 Years
Collect quality of life and health outcomes data on these patients.
Time frame: 30 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 7 Oct 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Diane C. Bodurka, MD principal investigator
M.D. Anderson Cancer Center
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 Ovarian Cancer, run by M.D. Anderson Cancer Center 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 3 inclusion and 4 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 7 Oct 2015. 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?
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). 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 7 Oct 2015.