A Phase 2 interventional study of Oncological Follow-up in Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor and Gastrointestinal Stromal Tumors, sponsored by Centre Oscar Lambret. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Health services research
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).
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 :
The exploratory objectives are to :
63 studies on the registry are indexed under Seminoma; 15 are open to participants now.
This study's planned enrollment of 88 is above the median of 50 across 47 interventional studies indexed under Seminoma.
Browse Seminoma studies →Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient with one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Telesurveillance by a nurse
Other: Oncological Follow-up
On-site surveillance by a hospital physician
Other: Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
2-year compliance to the customized surveillance plan
Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date
Time frame: 2 years
5-year compliance to the customized surveillance plan
Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date
Time frame: 5 years
Drop-out rate
Rate of patients lost to follow-up or quitting the surveillance program
Time frame: 5 years
Description of the use of care
* number of physical consultations at the investigator site * number of emergency room visits for oncological reasons * number of extra-hospital consultations for oncological reasons
Time frame: 5 years
Occurrence and management of oncological events
Occurence and type of oncological event : relapse/progression. The management of oncological events will be evaluated according to three criteria : * completion of an oncological surgery * implementation of a treatment by radiotherapy * implementation of a systemic therapy such as chemotherapy
Time frame: 5 years
Progression-free survival
Time from randomization to first oncological event (progression/relapse) or death from any cause.
Time frame: 5 years
Overall survival
Time from randomization to death from any cause
Time frame: 5 years
Support care needs identified
Support care needs include : * algology consultation * nutrition/diet consultation * psycho-oncology consultation * social worker consultation * job retention consultation
Time frame: 2 years (early termination in case of relapse of the disease)
Costs in terms of medical transport use
Medical transport includes light medical vehicles and ambulances
Time frame: 5 years
Salary mass mobilized from a hospital perspective in both arms
Salary mass mobilized from a hospital perspective in both arms
Time frame: 5 years
Patient satisfaction
Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology
Time frame: 2 years
Patient reported outcomes
Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.
Time frame: 2 years
Evaluation of the causes of recruitment failures
In each investigating site, a screening log will be completed to find out the reasons for recruitment failures
Time frame: During the recruiting period (18 months)
Started Feb 2024 (actual). Primary completion is estimated for Oct 2026, 32 months after the start.
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