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出境医 / 临床实验 / A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study (NTRK)

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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

Eligibility Criteria
Layout table for eligibility information
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.

Contacts and Locations

Locations
Layout table for location information
France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Bayer
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date December 23, 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019) 		Frequency of NTRK fusions in subjects with locally advanced/unresectable or metastatic solid tumors. [ Time Frame: Retrospective analysis between January 2019 and December 2020 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 3, 2019)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study
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.
Brief Summary This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Parrafin embedded tumor material
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.
Condition Metastatic Solid Tumors
Intervention Other: Retrospective cohort
Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.
Study Groups/Cohorts Retrospective cohort
For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341).
Intervention: Other: Retrospective cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 3, 2019) 		3750
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010240
Other Study ID Numbers IB2015-NTRK
MR 0112040319 ( Other Identifier: Insitut National des Données de Santé (INDS) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Bergonié
Study Sponsor Institut Bergonié
Collaborators Bayer
Investigators Not Provided
PRS Account Institut Bergonié
Verification Date July 2019

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