Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Data Collection for Patients With Low Grade Ovarian Carcinoma

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

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (electronic health record review)<br>Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored. | Procedure: Biospecimen Collection<br>* Patients' residual tissue samples are collected<br>Other: Electronic Health Record Review<br>* Medical records are reviewed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective and retrospective data collection on disease characterization, treatment, and outcomes |  | Up to 28 years | 
| Organization of clinical information | 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. | Up to 28 years | 
| Creation of a single data repository to integrate clinical information and research findings |  | Up to 28 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection and storage of human tumor samples for the establishment of a tumor bank |  | Up to 28 years |