Spectroscopy Versus Standard Care in Cervical Cancer Patients

NCT00529464 | Terminated Phase 3 Results DMC

• 1 other identifier: 2006-0582
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

Brief Summary

Primary objectives

1. 1.To conduct a randomized clinical trial of the emerging technology fluorescence and reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively.
2. 2.To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone.
3. 3.To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer.
4. 4.To study the number of LEEP specimens that show HGSIL or cancer.

Conditions

Cervical Cancer

Keywords

Cervical Intraepithelial Neoplasia; Cervical Dysplasia; Cervical Cancer; Fluorescence Spectroscopy; Colposcopy; Loop Electrical Excision Procedure; LEEP

Outcome Measures

Primary Outcomes (1)

• Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)

  A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.

  Up to 2 years

Study Arms (3)

Colposcopy

EXPERIMENTAL

Colposcopy - a direct magnified inspection of cervix

Procedure: Colposcopy

Colposcopy + Fluorescence Spectroscopy

EXPERIMENTAL

Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.

Procedure: Fluorescence Spectroscopy; Procedure: Colposcopy

Colposcopy + LEEP Procedure

EXPERIMENTAL

Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.

Procedure: Colposcopy; Procedure: LEEP Procedure

Interventions

Fluorescence Spectroscopy PROCEDURE

Pictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue.

Colposcopy + Fluorescence Spectroscopy

Colposcopy PROCEDURE

A standard colposcopy will be performed.

Colposcopy; Colposcopy + Fluorescence Spectroscopy; Colposcopy + LEEP Procedure

LEEP Procedure PROCEDURE

A small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam.

Also known as: Loop Electrical Excision Procedure

Colposcopy + LEEP Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Non-pregnant
• Patients with abnormal smears with cervical intraepithelial neoplasia (both low grade squamous intraepithelial lesions and high grade squamous intraepithelial lesions equal to cervical intraepithelial neoplasia 1-3)

You may not qualify if:

• Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in this study, since the chemotherapy often induces change in the cervix.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

British Columbia Cancer Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

Spectrometry, Fluorescence; Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Limitations and Caveats

This study was terminated due to difficulty enrolling subjects.

Results Point of Contact

• Title: Helen E. Rhodes, MD / Assistant Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-2933

Study Officials

• Helen E. Rhodes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 9, 2016
• Results First Posted: December 8, 2010

Record last verified: 2012-12

Locations

CA (1); US (2)