NCT03646422

Brief Summary

Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
unknown

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 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8.3 years

First QC Date

July 18, 2018

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maximum TNM stage

    Proportion

    Through study completion, an average every 1 year

  • Therapeutic groups used

    Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)

    Through study completion, an average every 1 year

  • Mortality

    Rate

    Through study completion, an average every 1 year

Interventions

Eligibility Criteria

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

Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain

You may qualify if:

  • All consecutive patients with primary cutaneous lymphoma

You may not qualify if:

  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Clinic

Barcelona, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Spain

RECRUITING

Hospital General de Ciudad Real

Ciudad Real, Spain

RECRUITING

hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

RECRUITING

C.H.U. Insular-Materno Infantil

Las Palmas de Gran Canaria, Spain

RECRUITING

H.U. Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Madrid, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Spain

RECRUITING

CHOP-Hospital de Montecelo

Pontevedra, Spain

RECRUITING

H.U. Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

H.U. Virgen del Rocío

Seville, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Valencia-Clínico Malva-Rosa

Valencia, Spain

RECRUITING

Related Publications (1)

  • Penate Y, Servitje O, Machan S, Fernandez-de-Misa R, Estrach MT, Acebo E, Mitxelena J, Ramon MD, Florez A, Blanes M, Morillo M, Medina S, Bassas J, Zayas A, Espinosa P, Perez A, Gonzalez-Romero N, Dominguez JD, Muniesa C, Lopez Robles J, Combalia A, Yanguas I, Suh H, Polo-Rodriguez I, Bielsa I, Mateu A, Ferrer B, Descalzo MA, Garcia-Doval I, Ortiz-Romero PL. The First Year of the AEVD Primary Cutaneous Lymphoma Registry. Actas Dermosifiliogr (Engl Ed). 2018 Sep;109(7):610-616. doi: 10.1016/j.ad.2018.03.006. Epub 2018 Apr 19. English, Spanish.

    PMID: 29680323BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal ZoneLymphoma, Large B-Cell, DiffuseSezary SyndromeLymphoma, Extranodal NK-T-CellLymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pablo Ortiz, MD, PhD

    Hospital 12 de Octubre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Garcia-Doval, MD, PhD, MScEpid

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 24, 2018

Study Start

September 1, 2016

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations