Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003384
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
1999-11-01
Brief Title:
Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia andor Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance Agus or Agcus As a Potential Diagnostic Biomarker of Cervical DysplasiaNeoplasia
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia andor cancer The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia andor cancer
Detailed Description:
OBJECTIVES
I Evaluate the utility of MN protein a novel tumor-associated antigen as a potential diagnostic biomarker for cervical glandular andor squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance AGUS
II Measure the frequency and type of cervical pathology associated with the diagnosis of AGUS in these patients
III Determine whether the presence of a high-risk type of human papilloma virus HPV in a ThinPrep cervical cell specimen predicts the presence of cervical glandular andor squamous cell neoplasia in these patients
IV Determine the relationship between MN antigen expression and the presence of high-risk HPV in these patients
OUTLINE This is a multicenter study
Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage an excisional cone biopsy of the cervix with or without endocervical curettage or a hysterectomy Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker eg P16 expression
Patients who do not undergo hysterectomy are followed every 6 months for 2 years All other patients are followed at 4 26 and 30 weeks
I Evaluate the utility of MN protein a novel tumor-associated antigen as a potential diagnostic biomarker for cervical glandular andor squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance AGUS
II Measure the frequency and type of cervical pathology associated with the diagnosis of AGUS in these patients
III Determine whether the presence of a high-risk type of human papilloma virus HPV in a ThinPrep cervical cell specimen predicts the presence of cervical glandular andor squamous cell neoplasia in these patients
IV Determine the relationship between MN antigen expression and the presence of high-risk HPV in these patients
OUTLINE This is a multicenter study
Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage an excisional cone biopsy of the cervix with or without endocervical curettage or a hysterectomy Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker eg P16 expression
Patients who do not undergo hysterectomy are followed every 6 months for 2 years All other patients are followed at 4 26 and 30 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0171 | OTHER | CTEP | None |
| NCI-2012-02269 | REGISTRY | None | None |
| CDR0000066380 | None | None | None |
| GOG-171 | OTHER | None | None |