NCT05373810

Brief Summary

The prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the Netherlands. All patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 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 Progress70%
Jul 2019Apr 2029

Study Start

First participant enrolled

July 29, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2029

Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

9.7 years

First QC Date

January 22, 2021

Last Update Submit

May 16, 2022

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    PFS

    up to 10 years

Secondary Outcomes (4)

  • Health related quality of life

    up to 5 years

  • grade 3/4 serious adverse events

    up to 5 years

  • Disease free survival

    up to 10 years

  • Overall survival

    up to 10 years

Interventions

SurgeryOTHER

all interventions are allowed

Also known as: Radiation, Systemic treatment

Eligibility Criteria

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

All patients diagnosed with bone or soft tissue sarcoma who are recently diagnosed, currently under treatment or have been treated will be asked to participate in this cohort study.

You may qualify if:

  • Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours

You may not qualify if:

  • Altered mental status that would prohibit the understanding of and giving of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiotherapiegroep

Arnhem, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Surgical Procedures, OperativeRadiationNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Physical PhenomenaCombined Modality TherapyTherapeutics

Central Study Contacts

Pètra Braam, MD/PhD

CONTACT

+31243614515p.braam@radboudumc.nl

Ingrid Desar, MD/PhD

CONTACT

+31243610353ingrid.desar@radboudumc.nl

Study Design

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

Study Record Dates

First Submitted

January 22, 2021

First Posted

May 13, 2022

Study Start

July 29, 2019

Primary Completion (Estimated)

April 2, 2029

Study Completion (Estimated)

April 2, 2029

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)