Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Recruiting now · Phase 2

Conditions studied: Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors, Ovarian Germ Cell Tumor, Adenocarcinoma, Clear Cell, Borderline Ovarian Tumor, Sex Cord-Stromal Tumor, Mucinous Adenocarcinoma of Ovary, Carcinoma, Small Cell, Carcinosarcoma, Ovarian, Serous Tumor of Ovary, Glioma, Neuroendocrine Tumors, Aggressive Fibromatosis of Abdominal Wall (Disorder)

In brief

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Key facts

Study ID

NCT05500391

Run by

Centre Oscar Lambret

People needed

88

Starts

2024-02-28

Expected to finish

2032-07-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive diagnosis (anatomopathology) of tumor within 12 months
• Patient 18 years of age or older
• Patient with one of the following conditions:
• Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
• Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
• Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
• Operated GIST with low risk of relapse
• Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
• Low-grade glioma, operated
• Low-grade neuroendocrine tumor, treated by surgery alone
• Patient who has given consent to participate in the study

You may not qualify if…

• Contraindication to imaging tests required for the surveillance plan
• No telephone
• Patient under guardianship or curatorship

Where it is running

• Centre Oscar Lambret — Lille, France (enrolling)
• CHU Amiens — Amiens, France
• Centre François Baclesse — Caen, France

Full record on ClinicalTrials.gov

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