Proteomic Profiling in Diagnosing Ovarian Cancer in Patie... | NCT00238342

ID	Type	Description	Link
GOG-0220

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Oct 2007Estimated

Completion Date

Not provided

First Submitted Date

Oct 12, 2005

First Submission Date that Met QC Criteria

Oct 12, 2005

First Posted Date

Oct 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2010

Last Update Posted Date

Feb 9, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

Detailed Description

OBJECTIVES:

Primary

Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.

Secondary

Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.

Tertiary

Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.
Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.
Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Measure	Description	Time Frame
Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Abnormal pelvic mass by physical examination or imaging test
- Undiagnosed
Planning to undergo surgical evaluation within the next 3 weeks

PATIENT CHARACTERISTICS:

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Surgery

See Disease Characteristics

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Elise C. Kohn, MD	NCI - Medical Oncology Branch	Study Chair
Samir N. Khleif, MD	National Cancer Institute (NCI)
Larry J. Copeland, MD	Ohio State University Comprehensive Cancer Center

Facility	Status	City	State	ZIP	Country	Contacts
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham		Birmingham	Alabama	35294	United States

Ancestor Terms

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005184	Fallopian Tube Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D004701	Endocrine Gland Neoplasms
D010049	Ovarian Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D005185	Fallopian Tube Neoplasms
D010051	Ovarian Neoplasms
D000077216	Carcinoma, Ovarian Epithelial

ID	Term
D019032	Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
D001706	Biopsy

ID	Term
D013058	Mass Spectrometry
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling
D003949	Diagnostic Techniques, Surgical
D013514	Surgical Procedures, Operative

Name	Type	Description	Arm Group Labels	Other Names
proteomic profiling	Genetic
surface-enhanced laser desorption/ionization-time of flight mass spectrometry	Other
biopsy	Procedure