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Blood Test for Ovarian Cancer Associated Antibodies (CAAb)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Lab Discoveries Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327925
First Posted: May 19, 2006
Last Update Posted: March 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lab Discoveries Ltd.
  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: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Study to Assess the Effectiveness of the CAAb Test With Ovarian Cancer Patients

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327925


Contacts
Contact: Alon Hayka, MA +972 544 631237 alonhayka@yahoo.com

Locations
Israel
Shiba Hospital Recruiting
Tel Hashomer, Tel Aviv, Israel
Contact: Gilad ben Baruch, Prof.    035303030      
Soroka Recruiting
Beer-Sheva, Israel
Contact: Alex Abonovitz, Dr.    972 523912216      
Principal Investigator: Binyamin Fiora, Prof         
Carmel Hospital Recruiting
Haifa, Israel
Contact: Ofer Lavie, Dr.    972 544 861003      
Principal Investigator: Ofer Lavie, Dr.         
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.         
Sponsors and Collaborators
Lab Discoveries Ltd.
Investigators
Principal Investigator: Tamar J. Cohen, Ph.D Lab Discoveries Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00327925     History of Changes
Other Study ID Numbers: LD-OC-CAAb
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: March 2, 2007
Last Verified: May 2006

Keywords provided by Lab Discoveries Ltd.:
Ovarian
Cancer
Antibodies
Ovarian Cancer Associated Antibodies

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs