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

NCT02251314 | Completed DMC

• 1 other identifier: 14-7467
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage correlation between circulating tumour DNA and metastatic sites

  3 years

Secondary Outcomes (1)

• Time to death

  2 years

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

UHN patients with BRAF mutant melanoma

You may qualify if:

• UHN adult patient with BRAF mutant melanoma

You may not qualify if:

• Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Pre-mortem bloods taken to obtain ctDNA * Post-mortem bloods and tissue To understand to what extent circulating DNA (found in Blood) represents the genetic content of underlying tumour metastases in BRAF mutant melanoma, and * To correlate the appearance of metastasis-specific mutations in the ctDNA with histological features in the tumours such as degree of necrosis, inflammation, microvascular density, and location or size of primary tumour and metastases

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Anthony Joshua, Dr.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 22, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

CA (1)