NCT03663647

Brief Summary

Retrospective chart review Study of patients with BRAF V600 positive advanced (unresectable or metastatic) melanoma, who were treated with targeted therapy in routine clinical practice in Russian Federation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2019

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

September 6, 2018

Last Update Submit

September 23, 2021

Conditions

Cutaneous Melanoma, Stage IVBRAF V600 Mutation

Outcome Measures

Primary Outcomes (1)

  • Approach to therapy in patients with metastatic or unresectable BRAF mutant melanoma

    Percentages of patients who were treated by targeted, immunotherapy and chemotherapy or other therapy types of treatment usage in each line of treatment

    4 years

Secondary Outcomes (8)

  • Overall survival (OS) of patients with stage III (unresectable) and stage IV BRAF V600-positive cutaneous melanoma

    5 years

  • Overall survival (OS) of patients with stage III (unresectable) and stage IV BRAF V600-positive cutaneous melanoma

    5 years

  • The response rate during therapy in patients with unresectable advanced BRAF mutant melanoma

    4 years

  • Disease control rate (DCR) in patients with unresectable advanced BRAF mutant melanoma

    4 years

  • Progression free survival (PFS) of patients with stage III (unresectable) and stage IV BRAF V600-positive cutaneous melanoma

    4 years

  • +3 more secondary outcomes

Other Outcomes (1)

  • Frequency of occurrence of any progression types on different treatments

    4 years

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with BRAF V600 advanced (unresectable or metastatic) cutaneous melanoma, who were treated by BRAFi or MEKi in routine clinical practice in Russian Federation

You may qualify if:

  • Histological confirmed cutaneous melanoma
  • BRAF V600 mutation
  • Treated by at least one therapy line including BRAFi / MEKi

You may not qualify if:

  • No data of targeted therapy usage and treatment outcomes (data of evaluation of effect and data of objective examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Moscow Regional Oncologic Dispensary

Balashikha, Russia

Location

Belgorod Oncologic Dispensary

Belgorod, Russia

Location

Republican Clinical Oncologic Dispensary

Cheboksary, Russia

Location

Kaluga Regional Clinical Oncologic Dispensary

Kaluga, Russia

Location

N.N. Blokhin National Medical Research Centre of Oncology

Moscow, Russia

Location

Clinical Oncologic Dispensary

Omsk, Russia

Location

City Clinical Oncologic Dispensary

Saint Petersburg, Russia

Location

N.N. Petrov National Medical Research Centre of Oncology

Saint Petersburg, Russia

Location

St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)

Saint Petersburg, Russia

Location

Tula Regional Oncologic Dispensary

Tula, Russia

Location

Voronezh Regional Clinical Oncologic Dispensary

Voronezh, Russia

Location

Related Publications (1)

  • Orlova KV, Ledin EV, Zhukova NV, Orlova RV, Karabina EV, Volkonskiy MV, Stroyakovskiy DL, Yurchenkov AN, Protsenko SA, Novik AV, Vorotilina LV, Moiseenko FV, Chang VL, Kazmin AI, Tkachenko SA, Gamaunov SV, Naskhletashvili DR, Samoylenko IV, Vikhrova AS, Utyashev IA, Kharkevich GY, Petenko NN, Shubina IZ, Demidov LV. Real-World Experience with Targeted Therapy in BRAF Mutant Advanced Melanoma Patients: Results from a Multicenter Retrospective Observational Study Advanced Melanoma in Russia (Experience) (ADMIRE). Cancers (Basel). 2021 May 21;13(11):2529. doi: 10.3390/cancers13112529.

    PMID: 34064013RESULT

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kristina Orlova, MD, PhD

    Association Professional Melanoma Society (MELANOMA.PRO)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Сlinical Researcher

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 10, 2018

Study Start

October 8, 2018

Primary Completion

April 27, 2019

Study Completion

April 27, 2019

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

RU(11)