A Phase 3 interventional study of Thinprep and Hybrid capture 2 in Cervical Intraepithelial Neoplasia, sponsored by National Cancer Institute (NCI). Completed at 3 sites in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Screening
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.
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 of progression. Therefore, both high- and low-grade lesions were often managed with colposcopy and directed biopsy. It was anticipated that determining alternative management strategies would yield important potential benefits including fewer medical complications from over treatment, reduced patient anxiety associated with referral for cytologic abnormalities, as well as cost savings.
Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the 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 AL; Magee-Womens Hospital, Pittsburgh PA; University of Oklahoma, Oklahoma City OK; and University of Washington, Seattle 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 main results from ALTS showed that for women with ASCUS cytology, HPV triage was at least as safe as universal immediate colposcopy in the detection of high-grade lesion and would allow approximately half of women to return to routine follow up without additional procedures (colposcopy). No efficient triage strategy was identified for women with LSIL cytology.
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 5,060 is above the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL)
Exclusion Criteria:
Referred to colposcopy if cytology is high grade
Device: Thinprep
Referred to colposcopy if cytology is high grade or HPV +
Device: Hybrid capture 2
All refer to colposcopy
Procedure: Colposcopy
Pap test
Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III)
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.
Time frame: up to 2 years
Percentage of Participants With Cumulative Detection of Clinical Center Histologically Confirmed Cervical Intraepithelial Neoplasia 2 (CIN2) and Above (High Grade Lesion) Over the 2 Years of the Trial.
Cumulative detection of CIN2 and above was assessed by pathologists who reviewed specimens from cervical pelvic exams (i.e. thin prep pap test, Human papillomavirus (HPV) Deoxyribonucleic acid (DNA) test, and/or colposcopy). Pathologists graded the specimens from CIN2 (moderate grade lesion) to CIN3 (high grade lesion).
Time frame: up to 2 years
| Milestone | Cytology | Human Papillomavirus (HPV) | Colposcopy |
|---|---|---|---|
| Started | 1839 | 1385 | 1836 |
| Completed | 1414 | 1156 | 1485 |
| Not completed | 425 | 229 | 351 |
| Withdrew: Lost to follow-up | 425 | 229 | 351 |
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.
| percentage of participants | Cytology | Human Papillomavirus (HPV) | Colposcopy |
|---|---|---|---|
| Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III) | 10.93 | 10.25 | 10.84 |
Cumulative detection of CIN2 and above was assessed by pathologists who reviewed specimens from cervical pelvic exams (i.e. thin prep pap test, Human papillomavirus (HPV) Deoxyribonucleic acid (DNA) test, and/or colposcopy). Pathologists graded the specimens from CIN2 (moderate grade lesion) to CIN3 (high grade lesion).
| percentage of particpants | Cytology | Human Papillomavirus (HPV) | Colposcopy |
|---|---|---|---|
| Percentage of Participants With Cumulative Detection of Clinical Center Histologically Confirmed Cervical Intraepithelial Neoplasia 2 (CIN2) and Above (High Grade Lesion) Over the 2 Years of the Trial. | 16.69 | 18.12 | 20.75 |
Collected over Adverse events were to be collected up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytology | 0/1,839 (0%) | 0/1,839 (0%) | 0/1,839 (0%) |
| Human Papillomavirus (HPV) | 0/1,385 (0%) | 0/1,385 (0%) | 0/1,385 (0%) |
| Colposcopy | 0/1,836 (0%) | 0/1,836 (0%) | 0/1,836 (0%) |
| Age, Categorical(Participants) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| <=18 years | 103 | 63 | 99 | 265 |
| Between 18 and 65 years | 1729 | 1313 | 1729 | 4771 |
| >=65 years | 7 | 9 | 8 | 24 |
| Age, Continuous(years) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| Mean | 27.22 ± 8.73 | 28.28 ± 9.62 | 27.24 ± 8.90 | 27.52 ± 9.05 |
| Sex: Female, Male(Participants) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| Female | 1839 | 1385 | 1836 | 5060 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 81 | 65 | 84 | 230 |
| Not Hispanic or Latino | 1754 | 1317 | 1751 | 4822 |
| Unknown or Not Reported | 4 | 3 | 1 | 8 |
| Race (NIH/OMB)(Participants) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 41 | 27 | 40 | 108 |
| Asian | 48 | 57 | 65 | 170 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 559 | 427 | 569 | 1555 |
| White | 1180 | 865 | 1146 | 3191 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 9 | 16 | 36 |
| Region of Enrollment(Participants) | Cytology | Human Papillomavirus (HPV) | Colposcopy | Total |
|---|---|---|---|---|
| United States | 1839 | 1385 | 1836 | 5060 |
Plan to share: Yes — The only data sharing is in cervical images which are included as a part of a larger IRB approved release to collaborators completing a data sharing agreement that prohibits re-sharing of data images. The images are shared with limited test results, metadata, and age. The images are saved in encrypted files and shared under individual password protection. Images will only be shared with bonafide researchers who are verified and complete a pilot.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)