Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck

NCT05644457 | Recruiting

• 1 other identifier: CCR5397
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

DART is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (HNSCC)

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points

  Through study completion, expected duration of 5 years

Secondary Outcomes (5)

• To collect longitudinal biological samples, including blood, saliva and tissue, for molecular profiling

  Through study completion, expected duration of 5 years

• To collect tumour tissue to facilitate molecular analysis of recurrent or metastatic cancers of the head and neck.

  Through study completion, expected duration of 5 years

• To isolate live tumour and immune cells for studies of therapy resistance and biology in cancers of the head and neck.

  Through study completion, expected duration of 5 years

• Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites.

  Through study completion, expected duration of 5 years

• To correlate assays with clinicopathological data.

  Through study completion, expected duration of 5 years

Study Arms (1)

Patients receiving systemic therapies for cancers of the head and neck

Patients undergoing systemic therapy for recurrent, metastatic, or locally advanced cancer of the head and neck not suitable for treatment with curative intent. A biological research study involving the collection of blood, tumour tissue, saliva, and other body fluids routinely examined during cancer care (e.g. cerebrospinal fluid (CSF), ascites, urine, stool or pleural fluids).

Genetic: Circulating tumour DNA dynamics

Interventions

Circulating tumour DNA dynamics GENETIC

Circulating tumour DNA (ctDNA) can be identified in patients with a wide variety of cancers and has been shown to allow early prediction of disease relapse after treatment with curative intent in HNSCC.

Patients receiving systemic therapies for cancers of the head and neck

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

Patients undergoing systemic therapy for recurrent, metastatic, or locally advanced cancer of the head and neck not suitable for treatment with curative intent.

You may qualify if:

• Age 18 years or older
• Patients with histologically confirmed cancer of the head and neck with evidence of recurrent or locally advanced cancer not suitable for treatment with curative intent, or metastatic disease.
• Receiving immunotherapy
• Ability to give informed consent for biological sample collection.

You may not qualify if:

• Unable to undergo serial sample collection
• Pregnancy

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden Hospital

London, United Kingdom

RECRUITING

Related Publications (11)

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  PMID: 31679945 BACKGROUND

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  PMID: 26997480 BACKGROUND

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  PMID: 26940869 BACKGROUND

• Hanna GJ, Lizotte P, Cavanaugh M, Kuo FC, Shivdasani P, Frieden A, Chau NG, Schoenfeld JD, Lorch JH, Uppaluri R, MacConaill LE, Haddad RI. Frameshift events predict anti-PD-1/L1 response in head and neck cancer. JCI Insight. 2018 Feb 22;3(4):e98811. doi: 10.1172/jci.insight.98811. eCollection 2018 Feb 22.

  PMID: 29467336 BACKGROUND

• Riaz N, Havel JJ, Makarov V, Desrichard A, Urba WJ, Sims JS, Hodi FS, Martin-Algarra S, Mandal R, Sharfman WH, Bhatia S, Hwu WJ, Gajewski TF, Slingluff CL Jr, Chowell D, Kendall SM, Chang H, Shah R, Kuo F, Morris LGT, Sidhom JW, Schneck JP, Horak CE, Weinhold N, Chan TA. Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab. Cell. 2017 Nov 2;171(4):934-949.e16. doi: 10.1016/j.cell.2017.09.028. Epub 2017 Oct 12.

  PMID: 29033130 BACKGROUND

• Havel JJ, Chowell D, Chan TA. The evolving landscape of biomarkers for checkpoint inhibitor immunotherapy. Nat Rev Cancer. 2019 Mar;19(3):133-150. doi: 10.1038/s41568-019-0116-x.

  PMID: 30755690 BACKGROUND

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• O'Leary B, Hrebien S, Morden JP, Beaney M, Fribbens C, Huang X, Liu Y, Bartlett CH, Koehler M, Cristofanilli M, Garcia-Murillas I, Bliss JM, Turner NC. Early circulating tumor DNA dynamics and clonal selection with palbociclib and fulvestrant for breast cancer. Nat Commun. 2018 Mar 1;9(1):896. doi: 10.1038/s41467-018-03215-x.

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  PMID: 30541742 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Longitudinal biological samples including blood, saliva, stool and tissue

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Ben O'Leary

CONTACT

02071535337; ben.oleary@icr.ac.uk

Study Design

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

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 9, 2022
• Study Start: March 9, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)