RECRUITINGPhase 2INTERVENTIONAL
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Contraindication to imaging tests required for the surveillance plan
- No telephone
- Patient under guardianship or curatorship
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Locations (3)
CHU Amiens
Amiens, France
Centre François Baclesse
Caen, France
Centre Oscar Lambret
Lille, France