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Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

The Utility and Relevance of Exome Sequence Analysis and Circulating Tumour DNA in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02251314
Enrollment
12
Registered
2014-09-29
Start date
2014-09-30
Completion date
2018-04-22
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

BRAF mutant melanoma, circulation tumour DNA, tumour heterogeneity, liquid biopsy

Brief summary

Despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. Part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. In this trial, the investigators hope to better understand the evolution of BRAF melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour DNA.

Detailed description

Study population: BRAF mutant melanoma patients Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient. When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. The patient and the families will also be provided with an additional consent form for participation including blood sampling.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

UHN adult patient with BRAF mutant melanoma

Exclusion criteria

Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient

Design outcomes

Primary

MeasureTime frame
Percentage correlation between circulating tumour DNA and metastatic sites3 years

Secondary

MeasureTime frame
Time to death2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026