Squamous Cell CarcinomaNCT05048459
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
A study testing Standard surveillance, Telemedicine surveillance (tele-surveillance) and Questionnaires in people with Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Standard surveillance, Telemedicine surveillance (tele-surveillance) and Questionnaires
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- ECOG 0-3
- Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
- No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy.
- Post-treatment diagnostic imaging with either CT or MRI (recommended but not required)
- Able to speak and read English fluently
- Able to provide informed consent
Who cannot join
- Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities
- Incomplete response or recurrent disease on post-treatment PET/CT
- Completion of radiation and chemotherapy more than 9 months ago
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer With No Evidence of Disease on Post-Treatment Imaging
The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Standard surveillance, Telemedicine surveillance (tele-surveillance), Questionnaires
- Keywords
- Tele-Surveillance, Remote Symptom Monitoring, 21-347, HPV-associated Head and Neck Cancer
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard surveillanceOther
Participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed
Telemedicine surveillance (tele-surveillance)Other
The tele-surveillance visit occurs annually after completion of therapy and consists of a phone call with or without video conferencing between the patient and the treatment team (physician, nurse, and/ or nurse practitioner). The use of video conferencing is strongly encouraged. Clinic visits, endoscopies, and imaging studies can be performed at the discretion of the treatment team for concerning patient symptoms.
QuestionnairesOther
EORTC QLQ-C30 and EORTC QLQ-HN43 at 12 and 24 months, FACE-Questionnaire Module, Telehealth Usability Questionnaire, Telehealth Usability Questionnaire, Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction -Patient Satisfaction inventory
| Study group | Role | What they receive |
|---|---|---|
| Standard surveillance | Active comparator | This surveillance approach involves the participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed Receives: Other: Standard surveillance; Other: Questionnaires |
| Telemedicine surveillance (tele-surveillance) | Experimental | Tele-surveillance involves the participant staying at home while their healthcare providers follow their condition and give them the care they need. They can communicate with their healthcare team through face-to-face video conferencing on their desktop computer, laptop, smart phone, or tablet. They can also communicate with their healthcare team by phone. Receives: Other: Telemedicine surveillance (tele-surveillance); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients
Measured: 2 years
Secondary outcomes (1)
Locoregional recurrence (LRR)
Any pathologic evidence of tumor progression in the head and neck will be counted as a LRR. Patients without concerning symptoms as determined by the treating physician at the time of the tele-visit will be determined to be free of LRR. If imaging or biopsies or ordered at any time and are consistent with tumor progression, then these patients will be counted as having a LRR event. both the EORTC QLQ-C30 and EORTC QLQ-HN43 Scores of all scales and single-item measures range from 0 to 100 with higher scores indicating better quality of life.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Sep 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a 1:1 randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048459
- Sponsor's protocol ID
- 21-347
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Shang T, Raab G, Chen L, Yu Y, Shamseddine A, Riaz N, McBride SM, Gelblum D, Morris LG, Lee NY, Zakeri K. Impact of Surveillance Imaging in Patients With HPV-Associated Oropharyngeal Carcinoma Treated With Definitive Radiation and Chemotherapy. Am J Clin Oncol. 2025 Jan 1;48(1):28-33. doi: 10.1097/COC.0000000000001144. Epub 2024 Sep 25.
PubMed 39319705
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer With No Evidence of Disease on Post-Treatment Imaging
- ClinicalTrials.gov ID
- NCT05048459
- Acronym / sponsor ID
- 21-347
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Tele-Surveillance, Remote Symptom Monitoring, 21-347, HPV-associated Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Sep 2021 (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.
The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a 1:1 randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Standard surveillance | Active comparator | Other: Standard surveillance, Other: QuestionnairesThis surveillance approach involves the participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed |
| Telemedicine surveillance (tele-surveillance) | Experimental | Other: Telemedicine surveillance (tele-surveillance), Other: QuestionnairesTele-surveillance involves the participant staying at home while their healthcare providers follow their condition and give them the care they need. They can communicate with their healthcare team through face-to-face video conferencing on their desktop computer, laptop, smart phone, or tablet. They can also communicate with their healthcare team by phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- ECOG 0-3
- Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
- No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy.
- Post-treatment diagnostic imaging with either CT or MRI (recommended but not required)
Key exclusion criteria (3 listed)
- Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities
- Incomplete response or recurrent disease on post-treatment PET/CT
- Completion of radiation and chemotherapy more than 9 months ago
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 |
|---|---|---|
| Standard surveillanceParticipant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed | Other | Standard surveillance |
| Telemedicine surveillance (tele-surveillance)The tele-surveillance visit occurs annually after completion of therapy and consists of a phone call with or without video conferencing between the patient and the treatment team (physician, nurse, and/ or nurse practitioner). The use of video conferencing is strongly encouraged. Clinic visits, endoscopies, and imaging studies can be performed at the discretion of the treatment team for concerning patient symptoms. | Other | Telemedicine surveillance (tele-surveillance) |
| QuestionnairesEORTC QLQ-C30 and EORTC QLQ-HN43 at 12 and 24 months, FACE-Questionnaire Module, Telehealth Usability Questionnaire, Telehealth Usability Questionnaire, Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction -Patient Satisfaction inventory | Other | Standard surveillance, Telemedicine surveillance (tele-surveillance) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 2 years
PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients
1 secondary outcome
Locoregional recurrence (LRR)
Time frame: 2 years
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 2 Jun 2026.
- Derived from this study: PubMed 39319705Shang T, Raab G, Chen L, Yu Y, Shamseddine A, Riaz N, McBride SM, Gelblum D, Morris LG, Lee NY, Zakeri K. Impact of Surveillance Imaging in Patients With HPV-Associated Oropharyngeal Carcinoma Treated With Definitive Radiation and Chemotherapy. Am J Clin Oncol. 2025 Jan 1;48(1):28-33. doi: 10.1097/COC.0000000000001144. Epub 2024 Sep 25.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering 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 Standard surveillance, Telemedicine surveillance (tele-surveillance) and Questionnaires in people with Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site 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 7 inclusion and 3 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 2 Jun 2026. 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 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?
Progression-Free Survival (PFS) (time frame: 2 years). 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 NCT05048459, which also lists 1 linked publication.
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 2 Jun 2026.