NCT02788916

Brief Summary

The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

10 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

Study Start

First participant enrolled

September 25, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

May 23, 2016

Last Update Submit

March 17, 2017

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes

    Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.

    Up to 6 months

Secondary Outcomes (8)

  • Percentage of Participants with Each Subtypes of PTCL

    Up to 6 months

  • Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification

    Up to 6 months

  • Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL

    Up to 6 months

  • Correlation Between the Expression of CD30 and Lymphoid Lineage

    Up to 6 months

  • Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival

    Up to 6 months

  • +3 more secondary outcomes

Study Arms (1)

Cohort 1

Assessment of tumor biopsies and histological preparations of participants diagnosed with peripheral T-cell lymphoma (PTCL) in the six years between 01 January 2008 and 31 December 2013 will be performed.

Other: No Intervention

Interventions

No InterventionOTHER
Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants diagnosed with PTCL in the six years between 01 January 2008 and 31 December 2013 in the participating sites.

You may qualify if:

  • Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
  • Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
  • PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:
  • Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
  • Enteropathic T-cell lymphoma
  • Hepatosplenic T-cell lymphoma
  • Peripheral T-cell lymphoma, not otherwise specified
  • Angioimmunoblastic T-cell lymphoma
  • Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
  • Anaplastic large cell lymphoma, ALK-

You may not qualify if:

  • Participants with an unavailable history (lost, empty or not recoverable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Santiago de Compostela, A Coruna, Spain

Location

Unknown Facility

Barcelona, Barcelona, Spain

Location

Unknown Facility

Santander, Cantabria, Spain

Location

Unknown Facility

Córdoba, Cordoba, Spain

Location

Unknown Facility

Madrid, Madrid, Spain

Location

Unknown Facility

Majadahonda, Madrid, Spain

Location

Unknown Facility

Oviedo, Oviedo, Spain

Location

Unknown Facility

Salamanca, Salamanca, Spain

Location

Unknown Facility

Seville, Sevilla, Spain

Location

Unknown Facility

Valencia, Valencia, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Initial tumor biopsies and histological preparations, filed and previously anonymized, will be assessed.

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 2, 2016

Study Start

September 25, 2015

Primary Completion

November 10, 2016

Study Completion

January 12, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

ES(10)