Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00488878

Collaborator

(none)

2,000

Enrollment

Location

347.4

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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:

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.
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:

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.

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Primary Completion Date :

May 1, 2034

Anticipated Study Completion Date :

May 1, 2035

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Prospective and retrospective data collection on disease characterization, treatment, and outcomes [Up to 28 years]
Organization of clinical information [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.
Creation of a single data repository to integrate clinical information and research findings [Up to 28 years]

Secondary Outcome Measures

Collection and storage of human tumor samples for the establishment of a tumor bank [Up to 28 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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