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To see the early effect of sorafenib on brain, heart and reproductive functions in patients with fibromatosis

To see the early effect of sorafenib on cognition, cardiovascular and reproductive functions in patients with fibromatosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052509
Enrollment
50
Registered
2023-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: D219- Benign neoplasm of connective andother soft tissue, unspecified

Interventions

None listed

Sponsors

Desmoid Tumor Research Foundation (DTRF)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients more than 18 years with histologically proven diagnosis of fibromatosis 2. Started on sorafenib within previous 2-3 months of start of study 3. No previously diagnosed cardiovascular/ neurological/ menstrual problems 4. Has not received previous chemotherapy 5. Should be able to perform the cognitive tasks

Exclusion criteria

Exclusion criteria: Patients who canâ??t give informed consent

Design outcomes

Primary

MeasureTime frame
To study the early effect of sorafenib therapy on the cardiovascular, cognitive and reproductive functions in the patients with desmoid tumor Timepoint: Baseline, 3 month, 6 month and 12 month—

Secondary

MeasureTime frame
To study the association of primary outcomes with the dose and duration of sorafenib therapyTimepoint: Baseline, 3 month, 6 month and 12 month—

Countries

India

Contacts

Public ContactDr Sameer Rastogi

All India Institute of Medical Sciences

samdoc_mamc@yahoo.com9013231857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026