Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)

NCT05649865 | Recruiting

• 1 other identifier: 2022-04539-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV. The main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment. The participants will be asked to provide blood tests:

1. 1.before treatment
2. 2.weekly during the treatment
3. 3.on all scheduled follow-up appointments
4. 4.on all unplanned appointments where a relapse is suspected

Conditions

Oropharynx Squamous Cell Carcinoma

Keywords

Human papilloma virus; circulating HPV DNA

Outcome Measures

Primary Outcomes (1)

• The sensitivity of detectable ctHPVDNA one month after (c)RT completion

  To determine if detectable ctHPVDNA one month post (C)RT is useful to detect residual or recurrent tumours diagnosed within two years.

  From inclusion to two years after treatment

Other Outcomes (8)

• The correlation of ctHPVDNA with stage/tumour burden.

  2 weeks after inclusion

• The correlation of ctHPVDNA titer decay during treatment with residual tumour.

  From inclusion to 3 months after the end of treatment

• The correlation of ctHPVDNA levels with PET response and pathology reports for treatment evaluation.

  From inclusion to 6 months after the end of treatment

Study Arms (1)

Patients with HPV-positive OPC

Patients with HPV-positive OPC. They will provide blood samples before during and after treatment to evaluate treatment response and for early detection of recurrence

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood samples for analysis of circulating tumour HPVDNA

Patients with HPV-positive OPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients in the Southern Health Care Region of Sweden, referred to Skane University Hospital, Lund, Sweden for curative treatment of HPV-positive oropharyngeal cancer.

You may qualify if:

• Age \>18 years.
• Able to give informed consent.
• The patient will be treated with curative intent.

You may not qualify if:

• Patients with a short life expectancy, psychiatric or addictive disorders, or other medical conditions which might impair patient compliance may be excluded at the discretion of the investigator.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Dept. of ORL-HNS

Lund, Skåne County, 22185, Sweden

RECRUITING

Related Publications (7)

• Hammarstedt L, Lindquist D, Dahlstrand H, Romanitan M, Dahlgren LO, Joneberg J, Creson N, Lindholm J, Ye W, Dalianis T, Munck-Wikland E. Human papillomavirus as a risk factor for the increase in incidence of tonsillar cancer. Int J Cancer. 2006 Dec 1;119(11):2620-3. doi: 10.1002/ijc.22177.

  PMID: 16991119 BACKGROUND

• Haring CT, Dermody SM, Yalamanchi P, Kang SY, Old MO, Chad Brenner J, Spector ME, Rocco JW. The future of circulating tumor DNA as a biomarker in HPV related oropharyngeal squamous cell carcinoma. Oral Oncol. 2022 Mar;126:105776. doi: 10.1016/j.oraloncology.2022.105776. Epub 2022 Feb 17.

  PMID: 35183912 BACKGROUND

• Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4.

  PMID: 32017652 BACKGROUND

• Rutkowski TW, Mazurek AM, Snietura M, Hejduk B, Jedrzejewska M, Bobek-Billewicz B, d'Amico A, Piglowski W, Wygoda A, Skladowski K, Kolosza Z, Widlak P. Circulating HPV16 DNA may complement imaging assessment of early treatment efficacy in patients with HPV-positive oropharyngeal cancer. J Transl Med. 2020 Apr 15;18(1):167. doi: 10.1186/s12967-020-02330-y.

  PMID: 32293457 BACKGROUND

• Tanaka H, Takemoto N, Horie M, Takai E, Fukusumi T, Suzuki M, Eguchi H, Komukai S, Tatsumi M, Isohashi F, Ogawa K, Yachida S, Inohara H. Circulating tumor HPV DNA complements PET-CT in guiding management after radiotherapy in HPV-related squamous cell carcinoma of the head and neck. Int J Cancer. 2021 Feb 15;148(4):995-1005. doi: 10.1002/ijc.33287. Epub 2020 Sep 30.

  PMID: 32895945 BACKGROUND

• O'Boyle CJ, Siravegna G, Varmeh S, Queenan N, Michel A, Pang KCS, Stein J, Thierauf JC, Sadow PM, Faquin WC, Wang W, Deschler DG, Emerick KS, Varvares MA, Park JC, Clark JR, Chan AW, Busse PM, Corcoran RB, Wirth LJ, Lin DT, Iafrate AJ, Richmon JD, Faden DL. Cell-free human papillomavirus DNA kinetics after surgery for human papillomavirus-associated oropharyngeal cancer. Cancer. 2022 Jun 1;128(11):2193-2204. doi: 10.1002/cncr.34109. Epub 2022 Feb 9.

  PMID: 35139236 BACKGROUND

• Routman DM, Kumar S, Chera BS, Jethwa KR, Van Abel KM, Frechette K, DeWees T, Golafshar M, Garcia JJ, Price DL, Kasperbauer JL, Patel SH, Neben-Wittich MA, Laack NL, Chintakuntlawar AV, Price KA, Liu MC, Foote RL, Moore EJ, Gupta GP, Ma DJ. Detectable Postoperative Circulating Tumor Human Papillomavirus DNA and Association with Recurrence in Patients With HPV-Associated Oropharyngeal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):530-538. doi: 10.1016/j.ijrobp.2022.02.012. Epub 2022 Feb 12.

  PMID: 35157995 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

HPV DNA will be analyzed from the primary tumour tissue and circulating tumour HPV DNA will be analyzed in plasma.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Johanna Sjövall, MD,PhD

  Dept. of clincial sciences, Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Sjövall, MD, PhD

CONTACT

+4646172164; johanna.sjovall@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 14, 2022
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)