NCT00511615

Brief Summary

The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial variations in expression that correlate with the presence of cervical precancer. To gather feasibility data the investigators will:

  1. 1.Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).
  2. 2.After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high resolution optical images before and after applying contrast agents topically to the epithelial surface of the tissue for 30 minutes before rinsing.
  3. 3.Submit the specimen for histology, and have it sectioned and stained using both H\&E and immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

August 2, 2007

Last Update Submit

July 31, 2012

Conditions

Cervical Cancer

Keywords

Cervical Intraepithelial NeoplasiaLoop Electrosurgical Excision ProcedureCervical CancerColposcopyMolecular ImagingLEEP

Outcome Measures

Primary Outcomes (1)

  • To learn if a new type of contrast agent (a dye used in certain types of scans and microscope studies) can be used to detect cervical cancer and precancerous lesions better than standard contrast agents.

    4 Years

Study Arms (1)

1

Patients with cervical cancer scheduled to be treated with the LEEP procedure.

Procedure: Loop Electrosurgical Excision Procedure (LEEP)

Interventions

Loop Electrosurgical Excision Procedure (LEEP)PROCEDURE

Tissue sample removed from cervix using LEEP and contrast agent.

Also known as: LEEP
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cervical cancer scheduled to be treated with the LEEP procedure.

You may qualify if:

  • Patients who are 18 years of age or older.
  • Patients who are not pregnant.
  • Patients who are not HIV positive.
  • Patients who are scheduled to be treated for SIL with LEEP.

You may not qualify if:

  • Patients who are younger than 18 years of age.
  • Patients who are pregnant.
  • Patients who are HIV positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lyndon B. Johnson Hospital

Houston, Texas, 77030, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UT Health Science Center-Houston

Houston, Texas, 77030, United States

Location

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Aaron J, Nitin N, Travis K, Kumar S, Collier T, Park SY, Jose-Yacaman M, Coghlan L, Follen M, Richards-Kortum R, Sokolov K. Plasmon resonance coupling of metal nanoparticles for molecular imaging of carcinogenesis in vivo. J Biomed Opt. 2007 May-Jun;12(3):034007. doi: 10.1117/1.2737351.

    PMID: 17614715BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Officials

  • Michele Follen, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

March 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(3)CA(1)