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A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study (NTRK)

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: NCT04010240
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Institut Bergonié

Brief Summary:
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.

Condition or disease Intervention/treatment
Metastatic Solid Tumors Other: Retrospective cohort

Detailed Description:
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis. The tropomyosin receptor kinase (Trk) receptor family comprises 3 transmembrane proteins referred to as Trk A, B and C (TrkA, TrkB and TrkC) receptors that are encoded by the NTRK1, NTRK2 and NTRK3 genes, respectively. These receptor tyrosine kinases are expressed in human neuronal tissue and play an essential role in the physiology of development and function of the nervous system through activation by neurotrophins. Gene fusions involving NTRK genes lead to transcription of chimeric Trk proteins with constitutively activated or overexpressed kinase function conferring oncogenic potential. These genetic abnormalities have recently emerged as targets for cancer therapy, because novel compounds have been developed that are selective inhibitors of the constitutively active rearranged proteins. Developments in this field are being aided by next generation sequencing methods as tools for unbiased gene fusions discovery. However, the incidence of NTRK aberrations in solid tumors is unknown as well as the natural history of NTRK-rearranged tumors This study will provide better knowledge of NTRK gene fusion incidence to allow recommendations for pathological diagnosis.

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Study Type : Observational
Estimated Enrollment : 3750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Determine the Incidence of NTRK Fusions in Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors With NTRK Fusions and Related Treatment Outcomes.
Actual Study Start Date : December 23, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Retrospective cohort
For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341).
Other: Retrospective cohort
Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.




Primary Outcome Measures :
  1. Frequency of NTRK fusions in subjects with locally advanced/unresectable or metastatic solid tumors. [ Time Frame: Retrospective analysis between January 2019 and December 2020 ]

Secondary Outcome Measures :
  1. Treatment outcome in terms of objective response rate. [ Time Frame: Retrospective analysis between January 2019 and December 2020 ]
    ORR will be defined as the proportion of patients with objective response (complete or partial response) during the first-line anti-cancer therapy.

  2. Treatment outcome in terms of progression-free survival. [ Time Frame: Retrospective analysis between January 2019 and December 2020 ]
    PFS will be defined as the delay from the date of onset of first-line anti-cancer therapy to the date of progression.

  3. Treatment outcome in terms of objective response rate. [ Time Frame: Retrospective analysis between January 2019 and December 2020 ]
    OS will be defined as the delay from the date of start first-line anti-cancer therapy to the date of death (whatever the cause).


Biospecimen Retention:   Samples Without DNA
Parrafin embedded tumor material


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The cohort will included both adult and pediatric patients with metastatic solid tumors, who have received at least one systemic anti-cancer therapy for advanced disease and for which there is available both outcome information and tumor material.
Criteria

Inclusion Criteria:

  1. Age ≥ 1 month.
  2. Subject has/had a histologically or cytologically confirmed diagnosis of solid tumor including but not exclusively: soft tissue sarcoma, BRAF wild type melanoma, KRAS wild-type colorectal cancer, central nervous system, EGFR-wild type non-small cell lung cancer.
  3. Subject has locally advanced/unresectable or metastatic disease.
  4. Subject has received at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic disease for which there is available outcome information in terms of PFS, or the latter can be estimated based on the subject's records.
  5. Subject has tumor material available for immunoscreening (IHC for NTRK gene fusions).
  6. Written and voluntary informed consent understood, signed and dated, or a waiver of consent is granted according to French régulations.

Exclusion Criteria:

1. Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.


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): NCT04010240


Locations
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France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Bayer
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT04010240    
Other Study ID Numbers: IB2015-NTRK
MR 0112040319 ( Other Identifier: Insitut National des Données de Santé (INDS) )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
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
Keywords provided by Institut Bergonié:
Solid tumor
Metastatic
NTRK