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Trial Title:
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
NCT ID:
NCT05500391
Condition:
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)
Conditions: Official terms:
Adenocarcinoma
Neuroendocrine Tumors
Neoplasms, Germ Cell and Embryonal
Gastrointestinal Stromal Tumors
Seminoma
Carcinosarcoma
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Fibroma
Carcinoma, Small Cell
Fibromatosis, Aggressive
Sex Cord-Gonadal Stromal Tumors
Adenocarcinoma, Clear Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Oncological Follow-up
Description:
Post-cancer surveillance (including biological, clinical and imaging exams depending on
the condition)
Arm group label:
Control
Arm group label:
Experimental
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).
Detailed description:
The primary objective of this study is to compare 2-year compliance with the personalized
post-treatment surveillance plan between the two arms.
The secondary objectives are to compare between the two arms :
- Long-term compliance (5-year follow-up)
- Use of care
- Oncological events and their management
- Supportive care needs
The exploratory objectives are to :
- Evaluate the costs in terms of medical transportation
- Evaluate and compare patients' satisfaction and psychological well-being (in terms
of anxiety/depression)
- Evaluate the homogeneity of the impact of the intervention according to covariates
(gender, tumor pathology, occupational status, and center)
- Evaluate the reasons for recruitment failures
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Amiens
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Guillaume BONNET
Email:
bonnet.guillaume@chu-amiens.fr
Investigator:
Last name:
Guillaume BONNET
Email:
Principal Investigator
Investigator:
Last name:
Mathieu BOONE, MD
Email:
Sub-Investigator
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
François GERNIER
Email:
f.gernier@baclesse.unicancer.fr
Investigator:
Last name:
François GERNIER
Email:
Principal Investigator
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurence ROTSAERT
Email:
l-rotsaert@o-lambret.fr
Investigator:
Last name:
Laurence ROTSAERT
Email:
Principal Investigator
Investigator:
Last name:
Nicolas PENEL, MD
Email:
Sub-Investigator
Start date:
February 28, 2024
Completion date:
October 2029
Lead sponsor:
Agency:
Centre Oscar Lambret
Agency class:
Other
Collaborator:
Agency:
Canceropôle Nord Ouest
Agency class:
Other
Collaborator:
Agency:
Groupement Interrégional de Recherche Clinique et d'Innovation
Agency class:
Other
Source:
Centre Oscar Lambret
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05500391