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NCT05307939 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Oropharynx Cancer and Hpv, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 8
- Study locations
NCT05307939: Recruiting Phase 2 study of Oropharynx Cancer and Hpv, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05307939 is a Phase 2 study of Oropharynx Cancer and Hpv that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 131-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (77% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05307939, a Phase 2 study of Oropharynx Cancer and Hpv, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
To estimate pathologically confirmed progression free survival (pPFS) two years post-operatively in HPV associated OPC patients who undergo active surveillance.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2027-03-24 |
| Phase | Phase 2 |
What NCT05307939 shows while recruiting
NCT05307939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 131-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (77% lower).
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.
NCT05307939 lists 8 locations in 3 states (New York, New Jersey, Florida).
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.
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).
Who is sponsoring clinical trial NCT05307939?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05307939's enrollment target sits among peer trials
30 18th of 26 higher than 7 of 26 other Oropharynx Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharynx Cancer 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.
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