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NCT Number: NCT05373810

Registration Study Sarcoma

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiotherapiegroep, Arnhem, Netherlands

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About this study

The main objectives of this project are:

  • To improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the Netherlands
  • To start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death
  • To prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions.
  • To collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures.
  • To create a continuous basis for a large variety of research purposes including:
  • Prognostic and predictive research
  • Health care policies and cost-effectiveness studies

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SURGERY

Other

all interventions are allowed

Other names: Radiation, Systemic treatment

Primary outcomes

  1. Progression free survival

    Time frame: up to 10 years

    PFS

Secondary outcomes

  1. Health related quality of life

    Time frame: up to 5 years

    measured by EORTC QOL questionnaires

  2. grade 3/4 serious adverse events

    Time frame: up to 5 years

    AE

  3. Disease free survival

    Time frame: up to 10 years

    DFS

  4. Overall survival

    Time frame: up to 10 years

    OS

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Desar, MD/PhD

CONTACT

[email protected]

+31243610353

Pètra Braam, MD/PhD

CONTACT

[email protected]

+31243614515

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Radiotherapiegroep

Registry information

Official study title

Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
May 13, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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