Data Collection for Patients With Low Grade Ovarian Carcinoma - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00488878

Purpose

Primary Objectives:

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.
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.
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.

Condition	Intervention
Ovarian Cancer Peritoneum Tumors	Behavioral: Data Collection

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Data Collection for Patients With Low Grade Ovarian Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1000
Study Start Date:	May 2006
Estimated Primary Completion Date:	May 2034 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Ovarian Cancer Data Collection	Behavioral: Data Collection Data collection from ovarian cancer patients seen at M.D. Anderson since January, 1950.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488878

Contacts

Contact: Lisa Nathan

713-745-3837

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David Gershenson, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

David Gershenson, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( David Gershenson, MD/Chair )
Study ID Numbers:	2006-0137
Study First Received:	June 18, 2007
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00488878 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer
Ovarian Carcinoma
Low-Grade Serous Carcinoma
Low Malignant Potential

Peritoneum Tumors
Psammocarcinoma
Data Collection
Research Database

Study placed in the following topic categories:

Cystadenocarcinoma, Serous
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Ovarian Epithelial Cancer
Carcinoma
Genital Diseases, Female
Ovarian Cancer
Endocrinopathy
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Neoplasms by Histologic Type
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Carcinoma
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009