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NCT01131312 · ClinicalTrials.gov registry record · Phase 3
Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 5,060
- Enrollment target
NCT01131312: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01131312 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 5,060 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (555% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131312, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,060 participants
- Enrollment target
Study Summary
Approximately 65 million Pap smears are performed each year in the United States. The vast majority of results are negative (no abnormality identified) but about 5 percent to 8 percent are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of such lesions would progress to a cancer precursor without treatment. However, there is no way to determine morphologically which patients are at risk or progression. Therefore, both high- and low-grade lesions were often managed with colposcopy and directed biopsy. Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the Atypical squamous cells of undetermined significance (ASCUS)- Low grade squamous intraepithelial lesion (LSIL) Triage Study (ALTS) trial was to use the information we have gained about the role of HPV to design better treatment and prevention strategies to reduce the burden of cervical cancer and its precursors. ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2) repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV testing and repeat cytology in combination, with referral to colposcopy if either the HPV test is positive or the cytology shows a high grade lesion. Four Clinical Centers University of Alabama, Birmingham Alabama (AL); Magee-Womens Hospital, Pittsburgh Pennsylvania (PA); University of Oklahoma, Oklahoma City OK; and University of Washington, Seattle Washington (WA) enrolled approximately 5,000 women with recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for a total of 2 years. The ALTS database and ALTS specimens continue to be a valuable research resource in studies of cervical cancer precursors, screening tests, visual assessment of the cervix and investigation of biomarkers.
Primary Outcome
A cervical exam, pap test, human papilloma virus (HPV) deoxyribonucleic acid (DNA) test, and/or colposcopy was performed to detect whether or not a participant had CINIII. CINIII is defined as moderate or severe dysplasia or abnormal cells located on the cervix that can lead to cancer.
Interventions
- PROCEDURE Colposcopy
- DEVICE Thinprep
- DEVICE Hybrid capture 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,060 participants |
| Start Date | 2008-02-20 |
| Est. Completion | 2009-02-05 |
| Phase | Phase 3 |
What the finished NCT01131312 record still lists
NCT01131312 is an interventional study that assigns participants to a tested intervention. Its 5,060 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (555% higher).
The record links to 0 conditions, and to 3 interventions - of which Colposcopy is the first listed.
NCT01131312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131312 about?
NCT01131312 is a clinical study titled "Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)". Approximately 65 million Pap smears are performed each year in the United States. The vast majority of results are negative (no abnormality identified) but about 5 percent to 8 percent are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of such lesions would progr...
What is the current status of trial NCT01131312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,060 participants. The study started on 2008-02-20. Estimated completion is 2009-02-05.
What interventions are being tested in trial NCT01131312?
The interventions under investigation include: Colposcopy (PROCEDURE), Thinprep (DEVICE), Hybrid capture 2 (DEVICE).
Who is sponsoring clinical trial NCT01131312?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131312's enrollment target sits among peer trials
5,060 48th of 2000 higher than 1,953 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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