Desmoid TumorQUALIFIEDNCT04289077

Quality of Life of Patients With Desmoid-type Fibromatosis

An observational study of Desmoid Tumor and Desmoid-type Fibromatosis, run by Erasmus Medical Center at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Desmoid Tumor, Desmoid-type Fibromatosis
What is being tested?: Questionnaires
How many people: 156 participants
Where: 4 sitesin 2 countries
Study dates: 6 Aug 2020to 1 Feb 2021
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: Patients, aged ≥18 years, diagnosed with a histopathological proven DTF, regardless of disease stage and received treatment(s) who have received their last check-up of their DTF in one of the participating hospitals the hospital between October 2014 and July 2020.

Who may be able to join

Aged 18 years and older
Histopathological proven DTF, regardless of disease stage or treatment.
Diagnosed between January 1990 and July 2020, with a visit to the hospital for their DTF (between October 2014 and July 2020)
Sufficient Dutch language skills
Competent to complete a questionnaire
Written informed consent

Who cannot join

Familial adenomatous polyposis (FAP)

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Netherlands3 sites

3. Antoni van Leeuwenhoek Ziekenhuis (AVL) / The Netherlands Cancer Instituut , Amsterdam, The Netherlands
Amsterdam, 1066 CX
Radboud University Medical Center (MC), Nijmegen, The Netherlands
Nijmegen, 6525 GA
Erasmus MC Cancer Institute
Rotterdam, 3015 GD

Other trials in Netherlands

United Kingdom1 site

Royal Marsden NHS Foundation Trust
London, SW3 6JJ

Other trials in United Kingdom

About this study

Official title: The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis

Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients.

Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.

Read the detailed description

Objectives: The primary objective is to evaluate HRQoL problems in adult DTF patients. The secondary objectives are: 1) to compare the level of HRQoL of DTF patients to the general population, 2) to identify patient subgroups who are at risk for developing certain HRQoL problems, 3) to evaluate patient preferences regarding their health care needs for DTF.

Outline: All patients, aged above 18 years, with a histopathological proved DTF tumour and sufficient Dutch language skills who have received their last check-up in the hospital within the last five years (April 2014). Patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, EORTC QLQ-C30, DTF-specific questionnaire, and the EQ-5D-5L). Patients will only have to fill out these questionnaires once.

Conditions: Desmoid Tumor, Desmoid-type Fibromatosis
Being tested: Questionnaires
Keywords: Health-related quality of life, Quality of life
Medical subject headings: Desmoid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnairesOther
- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October

Study groups in NCT04289077
Study group	Role	What they receive
Patients with histopathological proven DTF		Not described Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
Each question will be scored: not at all (1), a little (2), quite a bit (3), very much (4). The scores of the EORTC-QLQ30 will be calculated using a Likert scale from 1-4. The scoring manual of the EORTC will be followed. After linear transformation, all scales and single item measures range in score from 0-100. Scores for each scale will be reported as mean (SD), or as median (IQR). A higher score on the functional scales and global quality of life means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints. The EORTC QLQ-C30 summary score will be calculated using the mean scores of the function scales and the reversed mean scores of the symptom scales and represented as the mean of the combined 13 QLQ-C30 scale scores (financial impact and global health status excluded). A higher summary score represented a better outcome.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
DTF-QoL questionnaire (Desmoid-type fibromatosis Quality of Life Questionnaire)
The scores for each item of the DTF-QoL will be calculated using a Likert scale from 1-4. The scores of each item will be calculated as mean ± SD, or as median (IQR). These scores (median or mean) will be reported per item.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0)
Measures health-related quality of life on five dimensions of health: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. Additionally two questions aim to rank a patients' health (scale 0-100, with 100 representing a better health). Each of the five dimensions can be divided into five levels of perceived problems: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level). Health states can be converted into single index values. The outcomes will be reported as frequency (proportion) of reported problems for each level and for each dimension. The Visual Analogue Scale (VAS) data will be presented as a mean value (SD). In case of skewed data, median values and IQR will be used.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.

Secondary outcomes (4)

EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
See primary outcome 1 for a detailed description of the EORTC QLQ-C30 questionnaire.
The median or mean values for each scale of the EORTC QLQ-C30 from DTF patients will be compared to the median or mean scores per scale of the general population.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Baseline questionnaire (version 1.0)
Subgroups will be created based on the information of the baseline questionnaire and will encompass: sex (male, female), age groups (categorized based by the median age and/or quartiles), primary treatment type (surgical resection, systemic treatment, radiotherapy, local treatment (e.g. cryoablation), ethnicity, educational level, relationship status, job demands, comorbidities, tumour location, and tumour recurrences.
Outcomes of this questionnaire will be descriptive and are expressed as numbers with corresponding percentages.
Mean or median scores of each scale (EORTC QLQ-C30, version 3.0), items (DTF-QoL, version 1,0) or frequency scores (EQ-5D-5L, version 1,0) will be calculated for each relevant subgroup.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Healt care utilization questionnaire (version 1.0)
The health care utilization questionnaire contains the following topics: satisfaction with received care, frequency of visits to the general practitioner / specialist, satisfaction with the follow-up schedule, preferences and needs for receiving care in a DTF expert centre, receiving additional care of support from professionals (medical and non-medical). Outcomes will be descriptive and reported in numbers and corresponding frequencies per answer option.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Decision making questionnaire (version 1.0)
Six questions were designed to obtain information on how patients make medical decisions, what their current role is and what their preferred role, and one question regarding their awareness of their choices, the benefits and risks of certain treatment and whether they received support an advice are designed. Two questions were designed to gain insight into the reasons for choosing an active form of treatment.
Outcomes of this questionnaire will be descriptive and expressed as numbers with corresponding percentages.
Measured: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 20201 Feb 2021

First posted28 Feb 2020
Study start6 Aug 2020
Primary completion1 Feb 2021
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Desmoid TumorStudies of the same condition, open and under way.
More trials run by Erasmus 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: Cross-sectional
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04289077
Sponsor's protocol ID: MEC-2019-0816
Acronym: QUALIFIED
Status last verified: Sep 2023
First submitted: 24 Feb 2020
Last updated: 7 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kasper B, Baumgarten C, Garcia J, Bonvalot S, Haas R, Haller F, Hohenberger P, Penel N, Messiou C, van der Graaf WT, Gronchi A; Desmoid Working Group. An update on the management of sporadic desmoid-type fibromatosis: a European Consensus Initiative between Sarcoma PAtients EuroNet (SPAEN) and European Organization for Research and Treatment of Cancer (EORTC)/Soft Tissue and Bone Sarcoma Group (STBSG). Ann Oncol. 2017 Oct 1;28(10):2399-2408. doi: 10.1093/annonc/mdx323.
PubMed 28961825
Posner MC, Shiu MH, Newsome JL, Hajdu SI, Gaynor JJ, Brennan MF. The desmoid tumor. Not a benign disease. Arch Surg. 1989 Feb;124(2):191-6. doi: 10.1001/archsurg.1989.01410020061010.
PubMed 2916941
Crago AM, Denton B, Salas S, Dufresne A, Mezhir JJ, Hameed M, Gonen M, Singer S, Brennan MF. A prognostic nomogram for prediction of recurrence in desmoid fibromatosis. Ann Surg. 2013 Aug;258(2):347-53. doi: 10.1097/SLA.0b013e31828c8a30.
PubMed 23532110
Gronchi A, Colombo C, Le Pechoux C, Dei Tos AP, Le Cesne A, Marrari A, Penel N, Grignani G, Blay JY, Casali PG, Stoeckle E, Gherlinzoni F, Meeus P, Mussi C, Gouin F, Duffaud F, Fiore M, Bonvalot S; ISG and FSG. Sporadic desmoid-type fibromatosis: a stepwise approach to a non-metastasising neoplasm--a position paper from the Italian and the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):578-583. doi: 10.1093/annonc/mdt485. Epub 2013 Dec 9.
PubMed 24325833
Gundle KR, Cizik AM, Jones RL, Davidson DJ. Quality of life measures in soft tissue sarcoma. Expert Rev Anticancer Ther. 2015 Jan;15(1):95-100. doi: 10.1586/14737140.2015.972947. Epub 2014 Nov 7.
PubMed 25377073
Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. doi: 10.1056/NEJMoa1805052.
PubMed 30575484
Husson O, Younger E, Dunlop A, Dean L, Strauss DC, Benson C, Hayes AJ, Miah A, van Houdt W, Zaidi S, Smith M, Williams J, Jones RL, van der Graaf WTA. Desmoid fibromatosis through the patients' eyes: time to change the focus and organisation of care? Support Care Cancer. 2019 Mar;27(3):965-980. doi: 10.1007/s00520-018-4386-8. Epub 2018 Aug 28.
PubMed 30155568
van Broekhoven DL, Grunhagen DJ, den Bakker MA, van Dalen T, Verhoef C. Time trends in the incidence and treatment of extra-abdominal and abdominal aggressive fibromatosis: a population-based study. Ann Surg Oncol. 2015 Sep;22(9):2817-23. doi: 10.1245/s10434-015-4632-y. Epub 2015 Jun 5.
PubMed 26045393
Bonvalot S, Ternes N, Fiore M, Bitsakou G, Colombo C, Honore C, Marrari A, Le Cesne A, Perrone F, Dunant A, Gronchi A. Spontaneous regression of primary abdominal wall desmoid tumors: more common than previously thought. Ann Surg Oncol. 2013 Dec;20(13):4096-102. doi: 10.1245/s10434-013-3197-x. Epub 2013 Sep 20.
PubMed 24052312
Penel N, Le Cesne A, Bonvalot S, Giraud A, Bompas E, Rios M, Salas S, Isambert N, Boudou-Rouquette P, Honore C, Italiano A, Ray-Coquard I, Piperno-Neumann S, Gouin F, Bertucci F, Ryckewaert T, Kurtz JE, Ducimetiere F, Coindre JM, Blay JY. Surgical versus non-surgical approach in primary desmoid-type fibromatosis patients: A nationwide prospective cohort from the French Sarcoma Group. Eur J Cancer. 2017 Sep;83:125-131. doi: 10.1016/j.ejca.2017.06.017. Epub 2017 Jul 20.
PubMed 28735069
Timbergen MJM, van de Poll-Franse LV, Grunhagen DJ, van der Graaf WT, Sleijfer S, Verhoef C, Husson O. Identification and assessment of health-related quality of life issues in patients with sporadic desmoid-type fibromatosis: a literature review and focus group study. Qual Life Res. 2018 Dec;27(12):3097-3111. doi: 10.1007/s11136-018-1931-3. Epub 2018 Jul 16.
PubMed 30014458
Nolte S, Liegl G, Petersen MA, Aaronson NK, Costantini A, Fayers PM, Groenvold M, Holzner B, Johnson CD, Kemmler G, Tomaszewski KA, Waldmann A, Young TE, Rose M; EORTC Quality of Life Group. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019 Jan;107:153-163. doi: 10.1016/j.ejca.2018.11.024. Epub 2018 Dec 19.
PubMed 30576971
Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MA, Velikova G, Aaronson NK; EORTC Quality of Life Group. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016 Jan;69:79-88. doi: 10.1016/j.jclinepi.2015.08.007. Epub 2015 Sep 28.
PubMed 26327487
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Desmoid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis
ClinicalTrials.gov ID: NCT04289077
Acronym / sponsor ID: QUALIFIED / MEC-2019-0816
Conditions: Desmoid Tumor, Desmoid-type Fibromatosis
Keywords: Health-related quality of life, Quality of life
Study type: Observational
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Collaborators: Radboud University Medical Center, The Netherlands Cancer Institute, Royal Marsden NHS Foundation Trust
Study start: 6 Aug 2020 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 28 Feb 2020 (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.

Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Patients with histopathological proven DTF	–	Other: Questionnaires

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients, aged ≥18 years, diagnosed with a histopathological proven DTF, regardless of disease stage and received treatment(s) who have received their last check-up of their DTF in one of the participating hospitals the hospital between October 2014 and July 2020.

Key inclusion criteria (6 listed)

Aged 18 years and older
Histopathological proven DTF, regardless of disease stage or treatment.
Diagnosed between January 1990 and July 2020, with a visit to the hospital for their DTF (between October 2014 and July 2020)
Sufficient Dutch language skills
Competent to complete a questionnaire

Key exclusion criteria (1 listed)

Familial adenomatous polyposis (FAP)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Questionnaires- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October	Other	Patients with histopathological proven DTF

Primary outcome

EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Each question will be scored: not at all (1), a little (2), quite a bit (3), very much (4). The scores of the EORTC-QLQ30 will be calculated using a Likert scale from 1-4. The scoring manual of the EORTC will be followed. After linear transformation, all scales and single item measures range in score from 0-100. Scores for each scale will be reported as mean (SD), or as median (IQR). A higher score on the functional scales and global quality of life means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints. The EORTC QLQ-C30 summary score will be calculated using the mean scores of the function scales and the reversed mean scores of the symptom scales and represented as the mean of the combined 13 QLQ-C30 scale scores (financial impact and global health status excluded). A higher summary score represented a better outcome.
DTF-QoL questionnaire (Desmoid-type fibromatosis Quality of Life Questionnaire)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
The scores for each item of the DTF-QoL will be calculated using a Likert scale from 1-4. The scores of each item will be calculated as mean ± SD, or as median (IQR). These scores (median or mean) will be reported per item.
EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Measures health-related quality of life on five dimensions of health: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. Additionally two questions aim to rank a patients' health (scale 0-100, with 100 representing a better health). Each of the five dimensions can be divided into five levels of perceived problems: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level). Health states can be converted into single index values. The outcomes will be reported as frequency (proportion) of reported problems for each level and for each dimension. The Visual Analogue Scale (VAS) data will be presented as a mean value (SD). In case of skewed data, median values and IQR will be used.

4 secondary outcomes

EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Baseline questionnaire (version 1.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Healt care utilization questionnaire (version 1.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Decision making questionnaire (version 1.0)
Time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Background: PubMed 28961825Kasper B, Baumgarten C, Garcia J, Bonvalot S, Haas R, Haller F, Hohenberger P, Penel N, Messiou C, van der Graaf WT, Gronchi A; Desmoid Working Group. An update on the management of sporadic desmoid-type fibromatosis: a European Consensus Initiative between Sarcoma PAtients EuroNet (SPAEN) and European Organization for Research and Treatment of Cancer (EORTC)/Soft Tissue and Bone Sarcoma Group (STBSG). Ann Oncol. 2017 Oct 1;28(10):2399-2408. doi: 10.1093/annonc/mdx323.
Background: PubMed 2916941Posner MC, Shiu MH, Newsome JL, Hajdu SI, Gaynor JJ, Brennan MF. The desmoid tumor. Not a benign disease. Arch Surg. 1989 Feb;124(2):191-6. doi: 10.1001/archsurg.1989.01410020061010.
Background: PubMed 23532110Crago AM, Denton B, Salas S, Dufresne A, Mezhir JJ, Hameed M, Gonen M, Singer S, Brennan MF. A prognostic nomogram for prediction of recurrence in desmoid fibromatosis. Ann Surg. 2013 Aug;258(2):347-53. doi: 10.1097/SLA.0b013e31828c8a30.
Background: PubMed 24325833Gronchi A, Colombo C, Le Pechoux C, Dei Tos AP, Le Cesne A, Marrari A, Penel N, Grignani G, Blay JY, Casali PG, Stoeckle E, Gherlinzoni F, Meeus P, Mussi C, Gouin F, Duffaud F, Fiore M, Bonvalot S; ISG and FSG. Sporadic desmoid-type fibromatosis: a stepwise approach to a non-metastasising neoplasm--a position paper from the Italian and the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):578-583. doi: 10.1093/annonc/mdt485. Epub 2013 Dec 9.
Background: PubMed 25377073Gundle KR, Cizik AM, Jones RL, Davidson DJ. Quality of life measures in soft tissue sarcoma. Expert Rev Anticancer Ther. 2015 Jan;15(1):95-100. doi: 10.1586/14737140.2015.972947. Epub 2014 Nov 7.
Background: PubMed 30575484Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. doi: 10.1056/NEJMoa1805052.
Background: PubMed 30155568Husson O, Younger E, Dunlop A, Dean L, Strauss DC, Benson C, Hayes AJ, Miah A, van Houdt W, Zaidi S, Smith M, Williams J, Jones RL, van der Graaf WTA. Desmoid fibromatosis through the patients' eyes: time to change the focus and organisation of care? Support Care Cancer. 2019 Mar;27(3):965-980. doi: 10.1007/s00520-018-4386-8. Epub 2018 Aug 28.
Background: PubMed 26045393van Broekhoven DL, Grunhagen DJ, den Bakker MA, van Dalen T, Verhoef C. Time trends in the incidence and treatment of extra-abdominal and abdominal aggressive fibromatosis: a population-based study. Ann Surg Oncol. 2015 Sep;22(9):2817-23. doi: 10.1245/s10434-015-4632-y. Epub 2015 Jun 5.
Background: PubMed 24052312Bonvalot S, Ternes N, Fiore M, Bitsakou G, Colombo C, Honore C, Marrari A, Le Cesne A, Perrone F, Dunant A, Gronchi A. Spontaneous regression of primary abdominal wall desmoid tumors: more common than previously thought. Ann Surg Oncol. 2013 Dec;20(13):4096-102. doi: 10.1245/s10434-013-3197-x. Epub 2013 Sep 20.
Background: PubMed 28735069Penel N, Le Cesne A, Bonvalot S, Giraud A, Bompas E, Rios M, Salas S, Isambert N, Boudou-Rouquette P, Honore C, Italiano A, Ray-Coquard I, Piperno-Neumann S, Gouin F, Bertucci F, Ryckewaert T, Kurtz JE, Ducimetiere F, Coindre JM, Blay JY. Surgical versus non-surgical approach in primary desmoid-type fibromatosis patients: A nationwide prospective cohort from the French Sarcoma Group. Eur J Cancer. 2017 Sep;83:125-131. doi: 10.1016/j.ejca.2017.06.017. Epub 2017 Jul 20.
Background: PubMed 30014458Timbergen MJM, van de Poll-Franse LV, Grunhagen DJ, van der Graaf WT, Sleijfer S, Verhoef C, Husson O. Identification and assessment of health-related quality of life issues in patients with sporadic desmoid-type fibromatosis: a literature review and focus group study. Qual Life Res. 2018 Dec;27(12):3097-3111. doi: 10.1007/s11136-018-1931-3. Epub 2018 Jul 16.
Background: PubMed 30576971Nolte S, Liegl G, Petersen MA, Aaronson NK, Costantini A, Fayers PM, Groenvold M, Holzner B, Johnson CD, Kemmler G, Tomaszewski KA, Waldmann A, Young TE, Rose M; EORTC Quality of Life Group. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019 Jan;107:153-163. doi: 10.1016/j.ejca.2018.11.024. Epub 2018 Dec 19.
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.

C. Verhoef, MD, PhD principal investigator

Erasmus Medical Center

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Desmoid Tumor and Desmoid-type Fibromatosis, run by Erasmus Medical Center at 4 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 1 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0) (time frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.). The study lists 3 primary outcomes in all. 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 NCT04289077, which also lists 15 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 7 Sep 2023.