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Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

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ClinicalTrials.gov Identifier: NCT00488878
Recruitment Status : Recruiting
First Posted : June 20, 2007
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.

Condition or disease Intervention/treatment
Low Grade Ovarian Serous Adenocarcinoma Malignant Ovarian Neoplasm Ovarian Carcinoma Primary Peritoneal Carcinoma Primary Peritoneal Low Grade Serous Adenocarcinoma Psammocarcinoma Procedure: Biospecimen Collection Other: Electronic Health Record Review

Detailed Description:

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.

II. 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.

III. 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:

I. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank.

OUTLINE:

Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Data Collection for Patients With Low Grade Ovarian Carcinoma
Actual Study Start Date : May 19, 2006
Estimated Primary Completion Date : May 1, 2034
Estimated Study Completion Date : May 1, 2035


Group/Cohort Intervention/treatment
Observational (electronic health record review)
Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.
Procedure: Biospecimen Collection
Patients' residual tissue samples are collected

Other: Electronic Health Record Review
Medical records are reviewed




Primary Outcome Measures :
  1. Prospective and retrospective data collection on disease characterization, treatment, and outcomes [ Time Frame: Up to 28 years ]
  2. Organization of clinical information [ Time Frame: Up to 28 years ]
    Will be done 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. Creation of a single data repository to integrate clinical information and research findings [ Time Frame: Up to 28 years ]

Secondary Outcome Measures :
  1. Collection and storage of human tumor samples for the establishment of a tumor bank [ Time Frame: Up to 28 years ]

Biospecimen Retention:   Samples With DNA
Tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a low-grade tumor of Mullerian origin who sought treatment or a second opinion at MD Anderson Cancer Center (MDACC) at any point in the course of their disease and treatment (beginning in January 1950), and patients currently being treated at MDACC or seeking treatment or a second opinion in the future
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488878


Contacts
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Contact: Lisa Nathan 713-745-3837 lcnathan@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David M. Gershenson    713-563-4535      
Principal Investigator: David M. Gershenson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: David M Gershenson M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488878    
Other Study ID Numbers: 2006-0137
NCI-2020-13341 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006-0137 ( Other Identifier: M D Anderson Cancer Center )
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous