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RECRUITING Phase 2

A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)

NCT05307939 · View on ClinicalTrials.gov ↗

Study Summary

This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.

Interventions

  • DIAGNOSTIC_TEST HPV ctDNA Assay
  • DIAGNOSTIC_TEST MRI Studies
  • BEHAVIORAL EORTC QLQ H&N 35 and C30
  • BEHAVIORAL MDADI-HN
  • BEHAVIORAL COST-FACIT

Study Locations (8)

New York

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activites) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

New Jersey

  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale

Florida

  • Baptist Alliance MCI (Data Collection Only) — Miami

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-03-24
Est. Completion 2027-03-24
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05307939

The ClinicalTrials.gov registry entry for NCT05307939 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Oropharynx Cancer appearing as the primary indexed condition, and to 5 interventions — of which HPV ctDNA Assay is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05307939 reports 8 study locations spanning 3 distinct geographic areas — top geographies include New York, New Jersey, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05307939 about?

NCT05307939 is a clinical study titled "A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)". This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether mon...

What is the current status of trial NCT05307939?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-03-24. Estimated completion is 2027-03-24.

What conditions does trial NCT05307939 study?

This clinical trial studies the following conditions: Oropharynx Cancer, HPV, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma, HPV-Related Malignancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05307939?

The interventions under investigation include: HPV ctDNA Assay (DIAGNOSTIC_TEST), MRI Studies (DIAGNOSTIC_TEST), EORTC QLQ H&N 35 and C30 (BEHAVIORAL), MDADI-HN (BEHAVIORAL), COST-FACIT (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05307939?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05307939 being conducted?

This trial has 8 study locations across Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial