Blood Test for Ovarian Cancer Associated Antibodies (CAAb)

This study is currently recruiting participants.

Verified by Lab Discoveries Ltd., May 2006

First Received: May 18, 2006 Last Updated: March 1, 2007 History of Changes

Sponsored by:	Lab Discoveries Ltd.
Information provided by:	Lab Discoveries Ltd.
ClinicalTrials.gov Identifier:	NCT00327925

Purpose

Blood is collected from patients and cultured in a CimTube (a test tube with stimulation media) for several days.

Following the culture step, the supernatant fluid is tested for the presence of CAAb on experimental test kits.

Null Hypothesis: There is no relationship between the presence or absence of ovarian cancer (OC) and the CAAb i.e. d=0.

Alternative Hypothesis: The expectation of the CAAb in the cancer population differs from that of the control population, i.e. m1 is not equal to m2. Since the sign of the difference is not important, the test will be two-sided.

Condition	Intervention
Ovarian Cancer	Procedure: Find Cancer Associated Antibodies

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title:	Study to Assess the Effectiveness of the CAAb Test With Ovarian Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Lab Discoveries Ltd.:

Estimated Enrollment:	60
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Ovarian cancer patients:

Subjects 18 years or over.
Patients suspected of ovarian cancer (including peritoneal carcinoma). The clinical suspicion will include one of the following: pelvic mass (by pelvic examination or other imaging techniques), or high cancer antigen (CA)-125 levels in post-menopausal women, ascites, or due to incidental finding of distant metastasis. Final analysis will be done in relation to pathology only.
Patients willing to participate as evidenced by signing the written informed consent.

Control subjects:

Subjects 18 years or over
Patients willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

Ovarian cancer patients:

Subjects less than 18 years of age
Hematological malignancies
Previous ovarian tumor
Patients under active chemotherapy treatment
Patients not willing to sign written informed consent

Control subjects:

Subjects less than 18 years
Hematological malignancies
History of any past tumors
Other ovarian pathology
Patients who have been under anesthesia in the last 2 months
Patients treated with immunosuppressant drugs
Patients not willing to sign written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327925

Contacts

Contact: Alon Hayka, MA

+972 544 631237

alonhayka@yahoo.com

Locations

Israel
Hadassah Hospital, Ein Karem Campus	Recruiting
Jerusalem, Israel, 91120
Contact: Avraham Ben Shoshan, Dr. 972 2 6777111
Principal Investigator: Avraham Ben Shoshan, Dr.
Hadassah Hospital, Mt. Scopus Campus	Recruiting
Jerusalem, Israel, 91120
Contact: Inbar Ben Sachar, Dr. +972 2 6777111
Principal Investigator: Inbar Ben Sachar, Dr.
Carmel Hospital	Recruiting
Haifa, Israel
Contact: Ofer Lavie, Dr. 972 544 861003
Principal Investigator: Ofer Lavie, Dr.
Soroka	Recruiting
Beer-Sheva, Israel
Contact: Alex Abonovitz, Dr. 972 523912216
Principal Investigator: Binyamin Fiora, Prof
Israel, Tel Aviv
Shiba Hospital	Recruiting
Tel Hashomer, Tel Aviv, Israel
Contact: Gilad ben Baruch, Prof. 035303030

Sponsors and Collaborators

Lab Discoveries Ltd.

Investigators

Principal Investigator:

Tamar J. Cohen, Ph.D

Lab Discoveries Ltd.

More Information

No publications provided

Study ID Numbers:	LD-OC-CAAb
Study First Received:	May 18, 2006
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00327925 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Lab Discoveries Ltd.:

Ovarian
Cancer
Antibodies
Ovarian Cancer Associated Antibodies

Study placed in the following topic categories:

Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Genital Diseases, Female
Antibodies
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Antibodies
Neoplasms by Site
Endocrine Gland Neoplasms
Immunoglobulins

ClinicalTrials.gov processed this record on September 01, 2009