Serial Tumour Biopsies and Blood Biomarkers in Melanoma

NCT04493723 | Recruiting

• 3 other identifiers: CFTSp15718/NW/0515132792
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Recent advances in understanding how cancer develops and spreads have led to effective new treatments and improved outcomes for patients with melanoma. However, we know that these new treatments do not work for all patients: some do not respond to them and some initially respond but then develop resistance. The overall aim of this study will be to collect tumour biopsies, biomarkers present in the blood, and other biological specimens which can be used to try to understand why resistance to anti-cancer treatment occurs, and to develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant melanoma. The study will be open to NHS patients aged 16 and over, who have been diagnosed with advanced melanoma, and who will be receiving treatment for their disease as part of their routine care. Patients will be asked to provide samples from tumour biopsies before, during and after treatment. We will also ask for blood samples to look at biomarkers in the blood and see how these correspond with tumour samples, which will further help us to understand treatment response. Biomarkers are substances in the body that can be measured and help indicate how a disease is developing. It is hoped that soon we will be able to monitor cancer by analysing a patient's blood samples, thus reducing the need for biopsies. As blood tests could be taken more frequently, signs that patients are becoming resistant to treatments could be picked up sooner. As well as monitoring biomarkers, we would also like to understand what happens to the healthy cells surrounding the tumour during treatment. This will improve our understanding of how cells adapt and respond to treatments, and may eventually lead to the discovery of new biomarkers to help predict which patients will develop resistance to certain treatments.

Conditions

Melanoma

Keywords

Tumour Biopsy; Blood Biomarker

Outcome Measures

Primary Outcomes (1)

• The number of patients who consent to have additional samples taken for research purposes and the number of research samples collected.

  This is primarily a sample collection study, where tissue will be used in future experiments to further understand mechanisms of disease resistance. This study will however assess patients acceptability to enrol in a study, where biological samples are taken purely for research, and not part of routine care.

  Duration of study, 300 participants over 16 years

Study Arms (1)

All participants

All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes

Procedure: Surgery; Procedure: Venepuncture

Interventions

Surgery PROCEDURE

To collect tumour tissue

Also known as: Biopsy

All participants

Venepuncture PROCEDURE

To collect blood samples

All participants

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage III or IV melanoma undergoing systemic therapy at The Christie hospital

You may qualify if:

• Age of 16 years or more.
• Patients must have given written informed consent.
• Evidence of locally advanced or metastatic melanoma, i.e. stage III or IV disease.
• Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
• Full blood count and coagulation tests within acceptable parameters (if consenting to part A).

You may not qualify if:

• Inability to provide informed consent.
• History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).
• History of HIV, Hepatitis B/C or other transmissible human disease.
• Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

The Christie

Manchester, M20 4BX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour biopsies, whole blood and blood products

MeSH Terms

Conditions

Melanoma

Interventions

Surgical Procedures, Operative; Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lorigan, Prof

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gupta, Dr

CONTACT

0161 446 3472; avinash.gupta@christie.nhs.uk

Valpione, Dr

CONTACT

sara.valpione@christie.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 30, 2020
• Study Start: November 14, 2018
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)