Malignant Female Reproductive System NeoplasmNCT05556772
Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
A study testing Biospecimen Collection and Interview in people with Malignant Female Reproductive System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in Dominican Republic.
Trial summary
This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- Biospecimen Collection and Interview
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 619 participants
- Where
- 1 siteDominican Republic
- Study dates
- 14 Nov 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages 25 - 49 years old will be eligible to participate in the study
- Women living with HIV who have an intact cervix
- Intent to reside in the Santo Domingo area
- Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
- Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria
Who cannot join
- Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
- Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
- Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
- Women who have no history of vaginal sexual exposure will not be eligible for the study
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz"
Santo Domingo, 10302
About this study
Official title: Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.
Read the detailed description
OUTLINE:
Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.
- Being tested
- Biospecimen Collection, Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy when indicated
Collection of blood; urine; cervical, anal, vaginal samples
InterviewOther
Attend interview
| Study group | Role | What they receive |
|---|---|---|
| Screening (biospecimen collection, cytology, interview) | Experimental | Participants participate in an interview and clinical exam, lasting approximately 2 hours. Participants undergo vaginal self-sampling, cervical provider-sampling, and collection of blood and urine samples. Participants also undergo a pelvic exam. After first interview and clinical exam at enrollment, participants have two subsequent study visits over a 2 year period. Receives: Procedure: Biospecimen Collection; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start14 Nov 2022
- Primary completion31 Oct 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet), Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
- Responsible party
- Sponsor
- Investigators
- Margaret M. Madeleine, PhD, MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556772
- Sponsor's protocol ID
- RG1122164
- Other IDs
- NCI-2021-14229, RG1122164, ULACNET-302, U54CA242977, 10893
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of original data, data and specimens may be shared upon request with other investigators at academic or nonprofit institutions in a limited data set, as defined under HIPAA. The final dataset and specimens will be stripped of identifiers prior to release for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
- ClinicalTrials.gov ID
- NCT05556772
- Acronym / sponsor ID
- RG1122164
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet), Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.
Detailed description
OUTLINE:
Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (biospecimen collection, cytology, interview) | Experimental | Procedure: Biospecimen Collection, Other: InterviewParticipants participate in an interview and clinical exam, lasting approximately 2 hours. Participants undergo vaginal self-sampling, cervical provider-sampling, and collection of blood and urine samples. Participants also undergo a pelvic exam. After first interview and clinical exam at enrollment, participants have two subsequent study visits over a 2 year period. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women ages 25 - 49 years old will be eligible to participate in the study
- Women living with HIV who have an intact cervix
- Intent to reside in the Santo Domingo area
- Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
- Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria
Key exclusion criteria (4 listed)
- Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
- Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
- Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
- Women who have no history of vaginal sexual exposure will not be eligible for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy when indicatedCollection of blood; urine; cervical, anal, vaginal samples | Procedure or surgery | Screening (biospecimen collection, cytology, interview) |
| InterviewAttend interview | Other | Screening (biospecimen collection, cytology, interview) |
Primary outcome
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
Time frame: At baseline
Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes. After publication of original data, data and specimens may be shared upon request with other investigators at academic or nonprofit institutions in a limited data set, as defined under HIPAA. The final dataset and specimens will be stripped of identifiers prior to release for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret M. Madeleine, PhD, MPH principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection and Interview in people with Malignant Female Reproductive System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.