NCT03855592

Brief Summary

Epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

48 active sites

Status
recruiting

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 Progress98%
Jul 2018Jul 2026

Study Start

First participant enrolled

July 4, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

8 years

First QC Date

February 19, 2019

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Location of origin of the thromboembolytic event

    Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event.

    Baseline

  • Vessel of origin of the thromboembolytic event

    Distribution in the number of patients according to the type of vessel affected by the thromboembolytic event.

    Baseline

  • Thromboembolytic event diagnosis type

    Proportion of patients with incidental versus symptomatic thormboembolic events

    Baseline

  • Primary tumor at the time of the thromboembolic event

    Distribution of patients according to the organ affected by the primary tumor.

    Baseline

  • Tumor-Node-Metastasis classification

    Based on the American Joint Committee on Cancer 2018 Tumor-Node-Metastasis classification system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.

    Baseline

  • Time between cancer diagnosis and thromboembolic event

    Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event

    Baseline

  • Patient situation at the last visit

    Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.

    12 months

  • Characteristics of treatment administered for cancer

    Based on the number of patients prescribed with chemotherapy, radiation therapy, hormonal therapy, erythropoietin, transfusions, surgery, catheter, etc.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients

You may qualify if:

  • Over 18 years of age with a histologically confirmed diagnosis of malignant tumor.
  • Venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: Doppler echocardiography, computed tomography (CT) angiography, etc.
  • Signing of informed consent.

You may not qualify if:

  • Clinical diagnosis of thromboembolic event without radiological confirmation.
  • Presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event.
  • Each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. Patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

RECRUITING

Hospital Universitario de Torrevieja

Elche, Alicante, Spain

RECRUITING

Hospital Son Espases

Palma, Balearic Islands, Spain

RECRUITING

Institut Català D'Oncologia (ICO) L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

RECRUITING

Hospital De Sant Joan Despi Moissès Broggi

Sant Joan Despí, Barcelona, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

RECRUITING

Hospital de Especialidades de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

RECRUITING

Complejo Hospitalario Univ. de Santiago

Santiago de Compostela, La Coruña, Spain

RECRUITING

Hospital de Fuenlabrada

Fuenlabrada, Madrid, Spain

RECRUITING

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

RECRUITING

Hospital Infanta Cristina

Parla, Madrid, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Complejo Hospitalario Universitario de A Coruña

A Coruña, Spain

RECRUITING

Hospital Universitario San Juan de Alicante

Alicante, Spain

RECRUITING

Hospital Univesitario Torrecárdenas

Almería, Spain

RECRUITING

Complejo Hospitalario Universitario de Badajoz

Badajoz, Spain

RECRUITING

Hospital Clínic Barcelona

Barcelona, Spain

RECRUITING

Hospital de Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital de Basurto

Bilbao, Spain

RECRUITING

Hospital Universitario San Pedro de Alcántara

Cáceres, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital General Virgen de la Luz

Cuenca, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Spain

RECRUITING

Hospital Universitari Dr. Josep Trueta/Institut Català D'Oncología Girona

Girona, Spain

RECRUITING

Hospital Universitario de Jaén

Jaén, Spain

RECRUITING

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

RECRUITING

Hospital Central de la Defensa Gómez Ulla

Madrid, Spain

RECRUITING

Hospital Fundación Jimenez Díaz

Madrid, Spain

RECRUITING

Hospital MD Anderson Cancer Center Madrid

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario la Princesa

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Morales Meseguer

Murcia, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Spain

RECRUITING

Oncoavanze

Seville, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Spain

RECRUITING

MeSH Terms

Conditions

ThromboembolismNeoplasms

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Andres Muñoz, M.D.

    Hospital General Universitario Gregorio Marañón, Madrid

    STUDY CHAIR
  • José Muñoz Langa, M.D.

    Hospital Universitario y Politécnico La Fe, Valencia

    STUDY CHAIR
  • Alberto Carmona Bayonas, M.D.

    Hospital Universitario Morales Meseguer, Murcia

    STUDY CHAIR
  • Paula Jiménez Fonseca, M.D.

    Hospital Universitario Central de Asturias, Oviedo

    STUDY CHAIR
  • Pedro Pérez Segura, M.D.

    Hospital Universitario Clínico San Carlos, Madrid

    STUDY CHAIR
  • Eva Martínez de Castro, M.D.

    Hospital Universitario Marqués de Valdecilla, Santander

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 27, 2019

Study Start

July 4, 2018

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations