MelanomaNCT04493723
Serial Tumour Biopsies and Blood Biomarkers in Melanoma
An observational study of Melanoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Surgery and Venepuncture
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2018to Jul 2034
- Phase
- Observational
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stage III or IV melanoma undergoing systemic therapy at The Christie hospital
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valpione, Dr contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie
Manchester, M20 4BX
Dr Gupta, 0161 446 3472
About this study
Official title: Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Malignant Melanoma.
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.
Read the detailed description
This will be a prospective study recruiting patients who have been diagnosed wth advanced melanoma.
Participants will be asked to give informed consent before any samples are collected.
Participants will be asked to donate tissue and other biospecimens (see list below) that are surplus to clinical requirements if a participant is undergoing any of the following as part of their routine care:
- lymph node dissection
- sentinel lymph node biopsy as part of their normal care
- resection of metastatic skin lesions or visceral disease
- medical treatment for Stage IV disease Biospecimens include urine, stool, saliva, hair follicles, ascitic, pleural, pericardial or cerebrospinal fluid Collection of archival tumour tissue from previous biopsy/surgery that is surplus to clinical requirements will also be requested, where available.
Participants will be asked to consent to having easily accessible lesions biopsied or resected, which are not required for clinical reasons, but are for research purposes only. Participants can still be part of the study even if they do not agree to these extra, optional biopsies. Tissue samples from the surgical specimens and the original primaries will be examined to look for molecular markers to correlate with circulating tumour molecular markers.
Consent will be requested to grow cell lines from the donated tumour tissue and implant tumour tissue into mice to characterise the genetic changes seen in both CTCs and biopsies, in terms of resistance to targeted agents, in the lab setting. Consent to this part of the study will be optional.
A maximum of 50mls blood sample will be requested from participants before any intervention. Further blood samples (maximum of 50mls each time) will also be requested as follows:
- after surgery, on subsequent routine follow up at 3 months, and then 3 monthly thereafter (i.e. approximately 4 times in a year after the initial pre and post surgical specimens)
- at the time of disease recurrence
- If on treatment, then usually approximately 3 weeks after starting treatment, and then every 2 cycles of treatment
- at disease progression The samples will be tested for various circulating tumour biomarkers.
We will be asking a small group of patients, approx 20, to consent to weekly blood samples, for up to 8 weeks, for specific biomarker analyses.
Clinical data will be collected for each patient, looking at demographics, baseline haematology and biochemistry blood results, radiological extent of disease, time to disease progression, clinical and histological features of the primary. Patients will be followed up for approximately 10 years to assess their outcome.
- Conditions
- Melanoma
- Being tested
- Surgery, Venepuncture
- Keywords
- Tumour Biopsy, Blood Biomarker
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Biopsy
To collect tumour tissue
VenepunctureProcedure or surgery
To collect blood samples
| Study group | Role | What they receive |
|---|---|---|
| All participants | All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes Receives: Procedure: Surgery; Procedure: Venepuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of study, 300 participants over 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start14 Nov 2018
- Primary completionJul 2034 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Lorigan, Prof, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493723
- Sponsor's protocol ID
- CFTSp157
- Other IDs
- 18/NW/0515, 132792
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD