Quality of LifeQUESTNCT03441906
QUEST: QUality of Life and Experiences of Sarcoma Trajectories
An observational study of Quality of Life and Sarcoma, run by Radboud University Medical Center at 8 sites in 2 countries.
Trial summary
Background: The prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Sarcoma, Diagnostic Interval
- How many people
- 350 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 15 Feb 2018to Feb 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with sarcoma, see inclusion criteria
Who may be able to join
- Age at diagnosis ≥ 18 years
- Diagnosis of sarcoma (histology confirmed by sarcoma histopathologist; according to ICD-10-GM codes C40 and C41 for bone sarcoma and C49 for soft-tissue sarcoma)
- Able to communicate in English (or Dutch)
- Mental capacity to provide informed consent and to participate in the study (as determined by the referring health care professional)
- Patients must be able to complete questionnaires themselves
- Patients must be under treatment or follow-up at one of the participating hospitals.
Who cannot join
- Too ill to complete questionnaires (according to advice from (former) treating specialist)
- Patients with desmoids fibromatosis will be excluded because of the non-malignancy of the disease; and patients with gastrointestinal stromal tumours (GIST; ICD-10-GM codes C15-20, C26, C48 and C80) will be excluded.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Netherlands5 sites, 5 recruiting
- Recruiting
NKI-AVL
Amsterdam
Vicky Soomers
- Recruiting
UMCG
Groningen
Vicky Soomers, 0031243618800, Vicky.Soomers@radboudumc.nl
- Recruiting
LUMC
Leiden
Vicky Soomers
- Recruiting
Radboudumc
Nijmegen, 6525GA
Vicky Soomers, MSc, MD, 0243618800, Vicky.Soomers@radboudumc.nl
- Recruiting
Erasmus medical centre
Rotterdam
Vicky Soomers, 0031243618800, Vicky.Soomers@radboudumc.nl
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Orthopaedic Hospital
Birmingham
Vicky Soomers
- Recruiting
Royal Marsden NHS Foundation Trust
London
Vicky Soomers
- Recruiting
The Christie NHS Foundation Trust
Manchester
Vicky Soomers
About this study
Background:
The prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with different health systems. Comprehensive assessment of diagnostic delays and its determinants, including demographic, clinical, psychosocial and health care system factors, is necessary to improve referral pathways and come to best practice and patient reported outcomes for sarcoma patients.
Read more
Research questions to be answered:
This study aims to quantify diagnostic delay (including patient, general practitioner and system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the Netherlands and England; to comprehensively evaluate risk factors of diagnostic delay; determine the association between diagnostic delay and outcomes (health-related quality of life, quality-adjusted life years, patient satisfaction, TNM classification, time to local/distant relapse and overall survival); and to assess differences between both countries. This should lead to advices about faster referral where possible.
Read the detailed description
The researchers will conduct a longitudinal cohort study among all sarcoma patients (≥18 years of age) that will be newly diagnosed in 1.5 years period from October 1st 2017 to March 30st 2019 in one of the participating study centers (5 centers in The Netherlands, 3 centers in England).
Patients will be invited before the start of treatment (with a two months eligibility window) and receive a questionnaire on diagnostic delay, risk factors and patient-reported outcomes. The questionnaire on patient-reported outcomes will be completed again 3 months, 6 months, 1-year and 2 years later.
Data collection will be done within PROFILES, an international registry for cancer patient reported outcomes (www.profilesregistry.nl). Clinical data will be collected through cancer registries and the junior investigator will collect extra data from patients' records.
- Conditions
- Quality of Life, Sarcoma, Diagnostic Interval, Diagnostic Pathway, Care Needs
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Health-related quality of life
Measured: Baseline
Secondary outcomes (8)
Diagnostic interval
Time to diagnosis
Measured: Relationship between diagnostic interval and quality of life at baseline
Factors influencing diagnostic interval
Risk factors to experience a long diagnostic interval
Measured: At baseline
QALY
Quality adjusted life years
Measured: Baseline
Psychologic impact
several measures will be taken into account, such as HADS etc
Measured: 2 years
Change in quality of life
Change in QoL throughout follow up
Measured: 2 years
PFS
progression free survival
Measured: through study completion, an average of 2 years
OS
Overall survival
Measured: Through study completion, an average of 2 years
Change in QALY
Quality adjusted life years
Measured: Change from baseline throughout follow-up of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Feb 2018
- Primary completionSep 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winette van der Graaf, Prof, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441906
- Sponsor's protocol ID
- 2017-3881
- Acronym
- QUEST
- Status last verified
- Mar 2019
- First submitted
- 7 Feb 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holthuis EI, Soomers VLMN, Rafiq M, Jones RL, Hayes A, Van De Wal D, Drabbe C, Been LB, Bonenkamp H, van der Hage JH, Lee ATJ, Verhoef C, van Houdt WJ, Young RJ, Bae S, Andelkovic V, Hong AM, Connor J, Koops C, van der Graaf WTA, Husson O. Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study. BMJ Open. 2026 May 4;16(5):e114422. doi: 10.1136/bmjopen-2025-114422.
PubMed 42082226Soomers V, Desar IM, van de Poll-Franse LV, Husson O, van der Graaf WT. Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients. BMJ Open. 2020 Oct 26;10(10):e039309. doi: 10.1136/bmjopen-2020-039309.
PubMed 33109665
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUEST: QUality of Life and Experiences of Sarcoma Trajectories
- ClinicalTrials.gov ID
- NCT03441906
- Acronym / sponsor ID
- QUEST / 2017-3881
- Conditions
- Quality of Life, Sarcoma, Diagnostic Interval, Diagnostic Pathway, Care Needs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with different health systems. Comprehensive assessment of diagnostic delays and its determinants, including demographic, clinical, psychosocial and health care system factors, is necessary to improve referral pathways and come to best practice and patient reported outcomes for sarcoma patients.
Research questions to be answered:
This study aims to quantify diagnostic delay (including patient, general practitioner and system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the Netherlands and England; to comprehensively evaluate risk factors of diagnostic delay; determine the association between diagnostic delay and outcomes (health-related quality of life, quality-adjusted life years, patient satisfaction, TNM classification, time to local/distant relapse and overall survival); and to assess differences between both countries. This should lead to advices about faster referral where possible.
Detailed description
The researchers will conduct a longitudinal cohort study among all sarcoma patients (≥18 years of age) that will be newly diagnosed in 1.5 years period from October 1st 2017 to March 30st 2019 in one of the participating study centers (5 centers in The Netherlands, 3 centers in England).
Patients will be invited before the start of treatment (with a two months eligibility window) and receive a questionnaire on diagnostic delay, risk factors and patient-reported outcomes. The questionnaire on patient-reported outcomes will be completed again 3 months, 6 months, 1-year and 2 years later.
Data collection will be done within PROFILES, an international registry for cancer patient reported outcomes (www.profilesregistry.nl). Clinical data will be collected through cancer registries and the junior investigator will collect extra data from patients' records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sarcoma, see inclusion criteria
Key inclusion criteria (6 listed)
- Age at diagnosis ≥ 18 years
- Diagnosis of sarcoma (histology confirmed by sarcoma histopathologist; according to ICD-10-GM codes C40 and C41 for bone sarcoma and C49 for soft-tissue sarcoma)
- Able to communicate in English (or Dutch)
- Mental capacity to provide informed consent and to participate in the study (as determined by the referring health care professional)
- Patients must be able to complete questionnaires themselves
Key exclusion criteria (2 listed)
- Too ill to complete questionnaires (according to advice from (former) treating specialist)
- Patients with desmoids fibromatosis will be excluded because of the non-malignancy of the disease; and patients with gastrointestinal stromal tumours (GIST; ICD-10-GM codes C15-20, C26, C48 and C80) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life
Time frame: Baseline
Health-related quality of life
8 secondary outcomes
Diagnostic interval
Time frame: Relationship between diagnostic interval and quality of life at baseline
Factors influencing diagnostic interval
Time frame: At baseline
QALY
Time frame: Baseline
Psychologic impact
Time frame: 2 years
Change in quality of life
Time frame: 2 years
PFS
Time frame: through study completion, an average of 2 years
OS
Time frame: Through study completion, an average of 2 years
Change in QALY
Time frame: Change from baseline throughout follow-up of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 42082226Holthuis EI, Soomers VLMN, Rafiq M, Jones RL, Hayes A, Van De Wal D, Drabbe C, Been LB, Bonenkamp H, van der Hage JH, Lee ATJ, Verhoef C, van Houdt WJ, Young RJ, Bae S, Andelkovic V, Hong AM, Connor J, Koops C, van der Graaf WTA, Husson O. Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study. BMJ Open. 2026 May 4;16(5):e114422. doi: 10.1136/bmjopen-2025-114422.
- Derived from this study: PubMed 33109665Soomers V, Desar IM, van de Poll-Franse LV, Husson O, van der Graaf WT. Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients. BMJ Open. 2020 Oct 26;10(10):e039309. doi: 10.1136/bmjopen-2020-039309.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winette van der Graaf, Prof, MD principal investigator
Radboud University Medical Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Sarcoma, run by Radboud University Medical Center at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky Soomers, MSc, MD (0031243618800, Vicky.Soomers@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.