NCT05500391 Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
| NCT ID | NCT05500391 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Oscar Lambret |
| Condition | Stage I Testicular Seminoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 88 participants in total. It began in 2024-02-28 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Positive diagnosis (anatomopathology) of tumor within 12 months * Patient 18 years of age or older * Patient with one of the following conditions: 1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance 2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7) 3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy) 4. Operated GIST with low risk of relapse 5. 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 6. Low-grade glioma, operated 7. Low-grade neuroendocrine tumor, treated by surgery alone * Patient who has given consent to participate in the study Exclusion Criteria: * Contraindication to imaging tests required for the surveillance plan * No telephone * Patient under guardianship or curatorship
Contact & Investigator
PENEL Nicolas, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Oscar Lambret
Frequently Asked Questions
Who can join the NCT05500391 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage I Testicular Seminoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05500391 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05500391 currently recruiting?
Yes, NCT05500391 is actively recruiting participants. Contact the research team at l-rotsaert@o-lambret.fr for enrollment information.
Where is the NCT05500391 trial being conducted?
This trial is being conducted at Amiens, France, Caen, France, Lille, France.
Who is sponsoring the NCT05500391 clinical trial?
NCT05500391 is sponsored by Centre Oscar Lambret. The principal investigator is PENEL Nicolas, MD, PhD at Centre Oscar Lambret. The trial plans to enroll 88 participants.