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Data Collection for Patients With Low Grade Ovarian Carcinoma
This study is currently recruiting participants.
Study NCT00488878   Information provided by M.D. Anderson Cancer Center
First Received: June 18, 2007   Last Updated: September 14, 2009   History of Changes

June 18, 2007
September 14, 2009
May 2006
May 2034   (final data collection date for primary outcome measure)
To collect information regarding ovarian tumor of low malignant potential, a low-grade serous ovarian carcinoma, primary peritoneal tumor of low malignant potential, low-grade carcinoma of the peritoneum, or a psammocarcinoma. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
  • Collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1000 female patients with low-grade ovarian and peritoneal tumors. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
  • Organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
  • To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00488878 on ClinicalTrials.gov Archive Site
To maintain patients' information in research database to learn and better understand about specific tumor types and to help develop better treatments for them. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
Obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. [ Time Frame: 28 Years ] [ Designated as safety issue: No ]
 
Data Collection for Patients With Low Grade Ovarian Carcinoma
Data Collection for Patients With Low Grade Ovarian Carcinoma

Primary Objectives:

  1. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1000 female patients with low-grade ovarian and peritoneal tumors. These include ovarian tumors of low malignant potential, low-grade serous ovarian carcinoma, primary peritoneal tumors of low malignant potential, low-grade carcinomas of the peritoneum, and psammocarcinoma.
  2. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
  3. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.

Secondary Objective:

1. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. These samples will serve as the basis for future studies.

Low-grade tumors of female organs are considered rare. Because of this, doctors do not know the best treatment for these kinds of tumors. Researchers want to learn more about patients' experience with these types of cancer to help find ways to develop better therapies to treat them.

If you agree to take part in this study, information about your type of cancer, the type of treatment you had or are having, and details about your follow-up care will be entered into a research database. These data will be collected from patients seen at M. D. Anderson since January, 1950. This information will serve as a basis for research studies about patients with low-grade ovarian tumors.

Your data will mostly come from your M .D. Anderson medical record. However, information may also be requested from you, your local doctor, or an outside hospital. Information collected from sources other than M. D. Anderson will be included in your M. D. Anderson medical record as well as entered into this study's database.

Information may be directly collected from you, if there are additional questions not provided in your medical records, if your information is not complete, or if your information collected from other sources does not match what is in your M. D. Anderson medical record.

To help ensure confidentiality, the database will be password-protected with access strictly limited to study staff.

This research database will be updated at least once a year to include information about your current treatment and/or follow-up care. This information is usually collected from your M. D. Anderson medical record, or it may be necessary to contact you directly. This information will be collected indefinitely. If you wish to end your participation in this study, you may request that your data remain in the database or that your information be deleted from the database.

This is an investigational study. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.

 
Interventional
Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
  • Ovarian Cancer
  • Peritoneum Tumors
Behavioral: Data Collection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
 
May 2034   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients seen at M.D. Anderson Cancer Center with the following tumor types or diagnosis are eligible for inclusion in this database. This includes patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis:

    • Ovarian tumor of low malignant potential,
    • Low-grade serous carcinoma of the ovary,
    • Primary peritoneal tumor of low malignant potential,
    • Low-grade serous carcinoma of the peritoneum,
    • Psammocarcinoma

Exclusion Criteria: None

Female
 
No
Contact: Lisa Nathan 713-745-3837
United States
 
NCT00488878
David Gershenson, MD/Chair, U.T.M.D. Anderson Cancer Center
2006-0137
M.D. Anderson Cancer Center
 
Principal Investigator: David Gershenson, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP