Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Low Grade Ovarian Serous Adenocarcinoma; Primary Peritoneal Carcinoma; Malignant Ovarian Neoplasm; Ovarian Carcinoma; Psammocarcinoma; Primary Peritoneal Low Grade Serous Adenocarcinoma

Treatments: Other: Electronic Health Record Review; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT00488878

2006-0137

NCI-2020-13341 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,000 participants in 1 patient group

Observational (electronic health record review)

Description:

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

Treatment:

Procedure: Biospecimen Collection

Other: Electronic Health Record Review