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Blood Test for Ovarian Cancer Associated Auto Antibodies

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Eventus Diagnostics Ltd
Sponsor:
Information provided by (Responsible Party):
Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier:
NCT01334437
First received: April 12, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Blood Test for Ovarian Cancer Associated Auto Antibodies

Resource links provided by NLM:


Further study details as provided by Eventus Diagnostics Ltd:

Primary Outcome Measures:
  • Number of participants in each of the clinicaly defined groups (OC, suspected and control). [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum


Estimated Enrollment: 250
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.

Criteria

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • Less than 18 years of age
  • Hematological malignancies
  • Autoimmune disorders diagnosed patients.
  • Previous or current tumors
  • Patients under active chemotherapy treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334437

Contacts
Contact: Ofer Lavie, Professor 972-544-861003 Lavi_ofer@clalit.org.il

Locations
Israel
"Carmel" Medical Center Recruiting
Haifa, Israel, 34362
Contact: Ofet Lavi, Professor       Lavi_ofer@clalit.org.il   
Principal Investigator: Ofer Lavie, Professor         
Sponsors and Collaborators
Eventus Diagnostics Ltd
Investigators
Principal Investigator: Ofer Lavie, Professor Carmel Hospital
  More Information

No publications provided

Responsible Party: Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT01334437     History of Changes
Other Study ID Numbers: EventusDx_ovary_2011ver2
Study First Received: April 12, 2011
Last Updated: February 19, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Eventus Diagnostics Ltd:
blood test
ovarian cancer
Associated Auto Antibodies

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

ClinicalTrials.gov processed this record on November 27, 2014