Stage I Testicular SeminomaPhase 2SUR-CANNCT05500391
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
A Phase 2 study testing Oncological Follow-up in people with Stage I Testicular Seminoma and Stage I Testicular Nonseminomatous Germ Cell Tumor, run by Centre Oscar Lambret at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors
- What is being tested?
- Oncological Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Feb 2024to Jul 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- Contraindication to imaging tests required for the surveillance plan
- No telephone
- Patient under guardianship or curatorship
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Amiens
Amiens, 80054
Guillaume BONNET, bonnet.guillaume@chu-amiens.fr
Guillaume BONNET
- Not yet recruiting
Centre François Baclesse
Caen, 14076
François GERNIER, f.gernier@baclesse.unicancer.fr
François GERNIER
- Recruiting
Centre Oscar Lambret
Lille, 59020
Laurence ROTSAERT, l-rotsaert@o-lambret.fr
Laurence ROTSAERT
About this study
Official title: Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
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).
Read the 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
- Conditions
- Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors, Ovarian Germ Cell Tumor, Adenocarcinoma, Clear Cell, Borderline Ovarian Tumor
- Being tested
- Oncological Follow-up
- Medical subject headings
- Seminoma, Gastrointestinal Stromal Tumors, Adenocarcinoma, Clear Cell, Sex Cord-Gonadal Stromal Tumors, Carcinoma, Small Cell, Carcinosarcoma, Glioma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological Follow-upOther
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Telesurveillance by a nurse Receives: Other: Oncological Follow-up |
| Control | Other | On-site surveillance by a hospital physician Receives: Other: Oncological Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (7)
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
Measured: 5 years
Drop-out rate
Rate of patients lost to follow-up or quitting the surveillance program
Measured: 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
Measured: 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
Measured: 5 years
Progression-free survival
Time from randomization to first oncological event (progression/relapse) or death from any cause.
Measured: 5 years
Overall survival
Time from randomization to death from any cause
Measured: 5 years
Support care needs identified
Support care needs include :
- algology consultation
- nutrition/diet consultation
- psycho-oncology consultation
- social worker consultation
- job retention consultation
Measured: 2 years (early termination in case of relapse of the disease)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start28 Feb 2024
- Primary completionOct 2026 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stage I Testicular SeminomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- PENEL Nicolas, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500391
- Sponsor's protocol ID
- SUR-CAN-2201
- Other IDs
- 2022-A01482-41
- Acronym
- SUR-CAN
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174.
PubMed 20429948Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7.
PubMed 31280494Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018.
PubMed 30093916Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20.
PubMed 34922758Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4.
PubMed 32429987
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
- ClinicalTrials.gov ID
- NCT05500391
- Acronym / sponsor ID
- SUR-CAN / SUR-CAN-2201
- Conditions
- Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors, Ovarian Germ Cell Tumor, Adenocarcinoma, Clear Cell, Borderline Ovarian Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Oncological Follow-upTelesurveillance by a nurse |
| Control | Other | Other: Oncological Follow-upOn-site surveillance by a hospital physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Positive diagnosis (anatomopathology) of tumor within 12 months
- Patient 18 years of age or older
- Patient with one of the following conditions:
- Patient who has given consent to participate in the study
Key exclusion criteria (3 listed)
- Contraindication to imaging tests required for the surveillance plan
- No telephone
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncological Follow-upPost-cancer surveillance (including biological, clinical and imaging exams depending on the condition) | Other | Control, Experimental |
Primary outcome
2-year compliance to the customized surveillance plan
Time frame: 2 years
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
7 secondary outcomes
5-year compliance to the customized surveillance plan
Time frame: 5 years
Drop-out rate
Time frame: 5 years
Description of the use of care
Time frame: 5 years
Occurrence and management of oncological events
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Support care needs identified
Time frame: 2 years (early termination in case of relapse of the disease)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 20429948Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174.
- Background: PubMed 31280494Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7.
- Background: PubMed 30093916Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018.
- Background: PubMed 34922758Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20.
- Background: PubMed 32429987Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PENEL Nicolas, MD, PhD principal investigator
Centre Oscar Lambret
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncological Follow-up in people with Stage I Testicular Seminoma and Stage I Testicular Nonseminomatous Germ Cell Tumor, run by Centre Oscar Lambret at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence ROTSAERT (0320295860 / 0320295918, l-rotsaert@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year compliance to the customized surveillance plan (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500391, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.