Blood Test for Ovarian Cancer Associated Antibodies (CAAb)

NCT00327925 | Unknown

• 1 other identifier: LD-OC-CAAb
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

Ovarian; Cancer; Antibodies; Ovarian Cancer Associated Antibodies

Interventions

Find Cancer Associated Antibodies PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lab Discoveries Ltd.: lead

Study Sites (5)

Shiba Hospital

Tel Litwinsky, Tel Aviv, Israel

RECRUITING

Soroka

Beersheba, Israel

RECRUITING

Carmel Hospital

Haifa, Israel

RECRUITING

Hadassah Hospital, Ein Karem Campus

Jerusalem, 91120, Israel

RECRUITING

Hadassah Hospital, Mt. Scopus Campus

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Tamar J. Cohen, Ph.D

  Lab Discoveries Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Hayka, MA

CONTACT

+972 544 631237; alonhayka@yahoo.com

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: July 1, 2006
• Study Completion: June 1, 2008
• Last Updated: March 2, 2007

Record last verified: 2006-05

Locations

IL (5)