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Data Collection for Patients With Low Grade Ovarian Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488878
First received: June 18, 2007
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The goal of this psychosocial research study is to collect information on patients with one of the above-mentioned low-grade tumors. Researchers want to maintain these patients' information in a research database to help learn and better understand these tumor types and to help develop better treatments for them.


Condition Intervention
Ovarian Cancer
Peritoneum Tumors
Behavioral: Data Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Data Collection for Patients With Low Grade Ovarian Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Data Collection for Patients with Low Grade Ovarian Carcinoma [ Time Frame: 28 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

If patient gives consent, tumor tissue left over from earlier surgery or surgeries that is preserved in wax or on glass slides will be stored in a research tissue bank.


Estimated Enrollment: 1600
Study Start Date: May 2006
Estimated Primary Completion Date: May 2034 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 MD 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 MD Anderson medical record. However, information may also be requested from you, your local doctor, or an outside hospital. Information collected from sources other than MD Anderson will be included in your MD 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 MD 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 MD 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 1,600 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Department of Gynecologic Oncology or the Department of Gynecologic Medical Oncology at UT MD Anderson Cancer Center in Houston, Texas

Criteria

Inclusion Criteria:

1) 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:

1) None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Lisa Nathan 713-745-3837

Locations
United States, Texas
University of Texas MD 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488878     History of Changes
Other Study ID Numbers: 2006-0137
Study First Received: June 18, 2007
Last Updated: September 5, 2014
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

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014