Blood Test for Ovarian Cancer Associated Auto Antibodies
1 other identifier
observational
250
1 country
1
Brief Summary
Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary diagnostic techniques. Test Description: Blood is collected from patients and serum/plasma is tested for the presence of CAAA on experimental test kit. Objectives: To assess the effectiveness of the CAAA test. Target Population: The study population will include women that have been diagnosed with suspected ovarian cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer but verified by pathology/cytology as non-cancers and a control set of blood samples will be collected from age matched women with no history of cancer. Structure: Women that will be enrolled for the study will be checked for the presence of CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the physicians in the participating centers for the patient population and to the clinical history for the control population. Sample Size: The investigators will collect at least 50 patients verified by pathology/cytology and for each patient at least two aged matched healthy controls and two aged matched suspected but verified as non-cancers. Total amount at least 250 samples. (Multi center study, statistical rationale provided below). Primary Effectiveness Variables: The effectiveness of the test will be defined by the specificity of the test conditionally that the sensitivity is not lower than a pre-defined level of 95%. Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%. Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical trials. All data will be stored in a protected internet-based database, and any changes of the data will be traced and recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 20, 2014
February 1, 2014
2.6 years
April 12, 2011
February 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants in each of the clinicaly defined groups (OC, suspected and control).
5 years
Eligibility Criteria
The study population will include women that have been diagnosed with suspected ovarian cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer but verified by pathology/cytology as non-cancers and a control set of blood samples will be collected from age matched women with no history of cancer.
You may qualify if:
- years or over.
- Patients suspected of ovarian pathology. The clinical suspicion will include one of the following: Pelvic mass/cyst (by pelvic examination and/or other imaging techniques), and/or high CA-125 levels, and/or ascites, and/or due to incidental finding of distant metastasis. Final analysis will be done in relation to pathology/cytology results only.
- Patients scheduled laparotomy/laparoscopy/surgery, ideally before any of the above.
You may not qualify if:
- Less than 18 years of age
- Hematological malignancies
- Autoimmune disorders diagnosed patients.
- Previous or current tumors
- Patients under active chemotherapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"Carmel" Medical Center
Haifa, 34362, Israel
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofer Lavie, Professor
Carmel Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
June 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 20, 2014
Record last verified: 2014-02