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Cervical Adenosquamous CarcinomaNCT04574635

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

An observational study of Cervical Adenosquamous Carcinoma and Cervical Squamous Cell Carcinoma, Not Otherwise Specified, run by Mayo Clinic at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection
Type of treatment
Surgery or procedure
How many people
18 participants
Where
2 sitesUnited States
Study dates
17 Nov 2020to 30 Nov 2027
Phase
Observational
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women ages 18 and older presenting with p16-positive or HPV-positive invasive carcinoma of the cervix cancer with plan to undergo therapy at Mayo Clinic Rochester or the University of Minnesota.

Who may be able to join

  • Able to provide written consent
  • Patient has given permission to give tumor/blood sample for research testing
  • Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
  • Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
  • Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits
  • Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
Show all 9Show fewer
  • Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)
  • FIGO 2019 Stage IB2-IIIC or not a surgical candidate
  • Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy

Who cannot join

  • Other active malignancy =< 2 years prior to registration.
  • EXCEPTIONS: Non-melanotic skin cancer
  • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer
  • Pregnancy or lactation
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.

Being tested
Biospecimen Collection
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of blood samples

Study groups in NCT04574635
Study groupRoleWhat they receive
Definitive chemoradiotherapy patientsPatients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).
Receives: Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment

    The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.

    Measured: At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)

Secondary outcomes (7)

  1. ctDNA levels

    Will be associated with Federation of Gynecology and Obstetrics stage and assessed using linear regression, reporting the correlation as well as the model estimates.

    Measured: Baseline

  2. Clinical tumor response

    Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

    Measured: At post-treatment assessment, assessed up to 2 years

  3. Radiographic tumor response

    Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

    Measured: At post-treatment assessment, assessed up to 2 years

  4. Recurrence-free survival

    Baseline ctDNA and ctDNA at measured time points will be considered in Cox models.

    Measured: Up to 2 years

  5. Overall survival

    Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

    Measured: Up to 2 years

  6. ctDNA clearance kinetics

    Will be correlated with recurrence-free survival. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

    Measured: Up to 2 years

  7. ctDNA conversion

    Will be correlated during the active monitoring phase with recurrence-free survival.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start17 Nov 2020
  3. Primary completion10 Sep 2025
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574635
Sponsor's protocol ID
ROR1905
Other IDs
NCI-2020-06965, ROR1905, 19-011924
Status last verified
Oct 2025
First submitted
23 Sep 2020
Last updated
27 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Adenosquamous Carcinoma and Cervical Squamous Cell Carcinoma, Not Otherwise Specified, run by Mayo Clinic at 2 sites in United States.

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 9 inclusion and 5 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 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment (time frame: At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04574635.

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 27 Oct 2025.

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