Personalized Targeted Therapy in Refractory or Relapsed Cancer in Childhood

NCT ID: NCT02242552

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

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A new research paradigm that involves sequencing tumor DNA/RNA to identify driver mutations, select among the Health Canada approved drugs (for adult cancers) known to block certain oncogenic pathways, and recommend these drugs to the treating physician, without taking into account the tumor histology.

In this paradigm, the treatment is targeted to the actionable mutation(s) i.e. those driving oncogenesis. It is also personalized to the molecular signature of the patient's tumor, irrespective of its histopathological subtype. The experience of the investigators team in genomics, including next generation sequencing and bioinformatic analysis combined with the clinical expertise, bring at last this approach within our technical capacities. In parallel, the number of Health Canada-approved drugs (which have been tested in a pediatric setting) designed to interfere with oncogenesis pathways is increasing exponentially.

Detailed Description

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Conditions

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Pediatric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

At the time of enrollment:

* 21 year-old or less
* Poor prognosis biopsy-proven cancer of any type :
* Cancer (at initial diagnosis) known to be refractory to treatment
* Or cancer refractory to treatment
* Or relapsed cancer
* Written informed consent by patient, parents, or the legal guardians

Exclusion Criteria

* Estimated life expectancy of less than 3 months.
Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Monia Marzouki

Hematologist/Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monia Marzouki, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Monia Marzouki, MD

Role: CONTACT

514-345-4931 ext. 6316

Hemrique Bittencourt, MD

Role: CONTACT

514-345-4931 ext. 2724

Facility Contacts

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Dominique Lafrenière, BScN, DESS

Role: primary

514-345-4969

Mary-Ellen French, RN

Role: backup

514-345-4969

Other Identifiers

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Triceps

Identifier Type: -

Identifier Source: org_study_id

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