Clinical trial NCT00488878: Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors
Official title: Data Collection for Patients With Low Grade Ovarian Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Grade Ovarian Serous Adenocarcinoma
Malignant Ovarian Neoplasm
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Primary Peritoneal Low Grade Serous Adenocarcinoma
Psammocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Prospective and retrospective data collection on disease characterization, treatment, and outcomes
timeFrame: Up to 28 years
measure: Organization of clinical information
timeFrame: Up to 28 years
measure: Creation of a single data repository to integrate clinical information and research findings
timeFrame: Up to 28 years
Secondary outcomes:
measure: Collection and storage of human tumor samples for the establishment of a tumor bank
timeFrame: Up to 28 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David M Gershenson
role: PRINCIPAL_INVESTIGATOR
References: