Blood Test for Ovarian Cancer Associated Antibodies (CAAb)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Lab Discoveries Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Lab Discoveries Ltd.
Information provided by:
Lab Discoveries Ltd.
ClinicalTrials.gov Identifier:
NCT00327925
First received: May 18, 2006
Last updated: March 1, 2007
Last verified: May 2006
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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| 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 | |
| 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00327925 History of Changes |
| Other Study ID Numbers: | LD-OC-CAAb |
| Study First Received: | May 18, 2006 |
| Last Updated: | March 1, 2007 |
| Health Authority: | Israel: Ministry of Health |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013