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Advanced Melanoma in Russian Experience (ADMIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663647
Recruitment Status : Unknown
Verified October 2018 by Kristina Orlova, MD, PhD, MelanomaPRO, Russia.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Crocus Medical B.V.
Information provided by (Responsible Party):
Kristina Orlova, MD, PhD, MelanomaPRO, Russia

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

Condition or disease
Cutaneous Melanoma, Stage IV BRAF V600 Mutation

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentral Retrospective Chart Review Study of Targeted Therapy Use in Patients With BRAF V600 Advanced (Unresectable or Metastatic) Cutaneous Melanoma in Routine Clinical Practice in Russian Federation
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  1. Percentages of patients who were treated by targeted, immunotherapy and chemotherapy or other therapy types of treatment usage in each line of treatment [ Time Frame: 2011 - June 2018 ]

Secondary Outcome Measures :
  1. Overall survival (OS) of patients with stage III (unresectable) and stage IV BRAF V600-positive cutaneous melanoma [ Time Frame: 2011 - June 2018 ]
  2. Objective response rate (ORR) [ Time Frame: 2011 - June 2018 ]
  3. Time to response (TTR) [ Time Frame: 2011 - June 2018 ]
  4. Duration of response (DoR) [ Time Frame: 2011 - June 2018 ]
  5. Best overall response [ Time Frame: 2011 - June 2018 ]
  6. Treatment duration (TD) for each line of therapy [ Time Frame: 2011 - June 2018 ]
  7. Number of AE's related with therapy [ Time Frame: 2011 - June 2018 ]

Other Outcome Measures:
  1. Frequency of occurrence of any minimal mutational/genetic changes (amplification, overexpression and other) possibly associated with primary resistance [ Time Frame: 2011 - June 2018 ]
  2. Frequency of occurrence of any progression types on different treatments [ Time Frame: 2011 - June 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663647


Contacts
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Contact: Kristina V Orlova, MD, PhD +7 (962) 935-92-42 k.orlova@melanomapro.ru

Locations
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Russian Federation
Moscow Regional Oncologic Dispensary Recruiting
Balashikha, Russian Federation
Belgorod Oncologic Dispensary Recruiting
Belgorod, Russian Federation
Republican Clinical Oncologic Dispensary Recruiting
Cheboksary, Russian Federation
Kaluga Regional Clinical Oncologic Dispensary Recruiting
Kaluga, Russian Federation
N.N. Blokhin National Medical Research Centre of Oncology Recruiting
Moscow, Russian Federation
Clinical Oncologic Dispensary Recruiting
Omsk, Russian Federation
City Clinical Oncologic Dispensary Recruiting
Saint Petersburg, Russian Federation
N.N. Petrov National Medical Research Centre of Oncology Recruiting
Saint Petersburg, Russian Federation
St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology) Recruiting
Saint Petersburg, Russian Federation
Tula Regional Oncologic Dispensary Recruiting
Tula, Russian Federation
Voronezh Regional Clinical Oncologic Dispensary Recruiting
Voronezh, Russian Federation
Sponsors and Collaborators
MelanomaPRO, Russia
Crocus Medical B.V.
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Responsible Party: Kristina Orlova, MD, PhD, Senior Сlinical Researcher, MelanomaPRO, Russia
ClinicalTrials.gov Identifier: NCT03663647    
Other Study ID Numbers: ADMIRE
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas