NCT04248348

Brief Summary

During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date. Specifically focus will be on the following:

  • Number of thrombotic events
  • Anti-thrombotic management dosage \& duration
  • Any bleedings related to anticoagulation
  • Patients' adherence and compliance

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

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

December 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 22, 2020

Last Update Submit

January 28, 2020

Conditions

ThrombosisSolid Cancer

Keywords

ThrombosisCancerHeparin, Low Molecular Weight

Outcome Measures

Primary Outcomes (2)

  • Number of thrombotic events

    Measure the number of thrombotic events in the population

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

  • Number of bleedings related to anticoagulation

    Measure the number of observed bleeding events caused by the anticoagulation treatment

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

Secondary Outcomes (4)

  • Anticoagulation drug dosage

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

  • Anticoagulation drug duration

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

  • Patients' compliance to anticoagulation treatment

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

  • Anticoagulation drug agent

    Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)

Interventions

Low Molecular Weight HeparinDRUG

Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)

Eligibility Criteria

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

Solid cancer patients

You may qualify if:

  • Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy \>6 months
  • Signed informed consent

You may not qualify if:

  • Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
  • Age \< 18 years
  • ECOG performance status \>2
  • Life expectancy \<6 months
  • Not signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metaxa Hopital

Piraeus, Attica, Greece

RECRUITING

Related Publications (1)

  • Xynogalos S, Simeonidis D, Papageorgiou G, Pouliakis A, Charalambakis N, Lianos E, Mazlimoglou E, Liatsos AN, Kosmas C, Ziras N. Can thromboprophylaxis build a link for cancer patients undergoing surgical and/or chemotherapy treatment? The MeTHOS cohort study. Support Care Cancer. 2022 Aug;30(8):6973-6984. doi: 10.1007/s00520-022-07096-1. Epub 2022 May 12.

    PMID: 35552827DERIVED

MeSH Terms

Conditions

ThrombosisNeoplasms

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Nikos Ziras, MD

    Metaxa Hospital

    STUDY CHAIR

  • Spyridon Xynogalos, MD

    Metaxa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikos Ziras, MD

CONTACT

+306932748495zirasngr@otenet.gr

Spyridon Xynogalos, MD

CONTACT

+306932056426sxyn@otenet.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oncology Clinic

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 30, 2020

Study Start

December 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

GR(1)