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Study on growth behavior of desmoid tumors with monitoring.

GRAFITI study: A prospective registration study on growth behavior of aggressive fibromatosis without therapeutic intervention’

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27891
Enrollment
100
Registered
2014-08-01
Start date
2014-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive fibromatosis Desmoid tumors

Interventions

watchful waiting policy

Sponsors

Erasmus MC Cancer Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Histological evidence of aggressive fibromatosis. - Capable of undergoing MRI-scans and ultrasound. - Nu functional impairment due to the tumor. - Capable of understanding and signing informed consent.

Exclusion criteria

Exclusion criteria: - Patients under 18 years of age. - Personal of family history of FAP. - Intra-abdominal tumor localization. - Potential life treat or imminent functional impairment in case of tumor progression. - Unavoidable mutilation in case of tumor progression. - Severe pain associated with the tumor. - Patients who have undergoing local or systemic treatment for the present manifestation of aggressive fibromatosis.

Design outcomes

Primary

MeasureTime frame
To assess tumor progression in terms of objectifying and monitoring growth during watchful waiting policy as an initial treatment for extra-abdominal and abdominal wall aggressive fibromatosis.

Secondary

MeasureTime frame
To investigate quality of life during a watchful waiting approach. To analyze the willingness of patients to adhere to a watchful waiting policy. To analyze the value of clinicopathological factors, including CTNNB1-gene mutation, in predicting progression. In case of objectified progression: to analyze considerations for administered treatment.

Contacts

Public ContactD. Broekhoven, van

Erasmus MC Cancer Institute

d.vanbroekhoven@erasmusmc.nl+31 10 7041223

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)