Spectroscopy Versus Standard Care in Cervical Cancer Patients

Stopped early · Phase 3

Conditions studied: Cervical Cancer

In brief

Primary objectives 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. The number of clinically read referral Paps, clinically read UT MD Anderson Cancer Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image, that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL), Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality is present. 2. To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone. 1. To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer. 2. To study the number of LEEP specimens that show HGSIL or cancer.

Key facts

Study ID

NCT00529464

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2006-11-01

Expected to finish

2008-08-01

Last updated by the study team

2016-05-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States
• British Columbia Cancer Research Centre — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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