An interventional study of Active follow-up and Surgery in Paragangliomas, sponsored by Hospices Civils de Lyon. Not yet recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
Among 15 studies in Paraganglioma with a site in France — 4 open to participants now, 6 under way, none of them phase 3. Paraganglioma · France.
Among the 15 studies in Paraganglioma with a site in France, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2026, is one of 7 with no phase, and was the 15th registered.
107 studies on the registry are indexed under Paraganglioma; 48 are open to participants now.
Browse Paraganglioma studies →4 of the 15 studies in Paraganglioma with a site in France are open now. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Merck Sharp & Dohme LLC · Sites in France, United States, Australia and 19 more countries
Assistance Publique - Hôpitaux de Paris · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 36 Paraganglioma studies recruiting now, 21 (58%) set no upper age limit and 3 (8%) stop at 75 or younger; 12 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4
First in 2005; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 122 is above the median of 40 across 65 interventional studies indexed under Paraganglioma.
Median enrollment 65 across the 12 interventional studies, 132 across the 3 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
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4 of 15 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 2 studies filed under Paraganglioma — fewer than ten, so there is no comparison to draw.
1 of the studies in Paraganglioma with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05233878Hospices Civils de LyonPrognostic's Factors of Head and Neck Paragangliomas Evolution | 2027-06 |
Among the 15 studies in Paraganglioma with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Head and neck paragangliomas (HNPGs) are predominantly non-secreting, benign and slow-growing tumors. Although most patients remain asymptomatic, up to 30% develop symptoms related to local tumor growth and fewer than 5-10% develop metastatic disease. Surgery has long been considered the standard treatment, while radiotherapy and active surveillance represent alternative management strategies. Treatment-related morbidity and impaired quality of life have been reported in patients with HNPGs; however, the impact of immediate intervention compared with an initial active surveillance strategy has not been prospectively evaluated. This multicenter randomized controlled trial aims to compare active surveillance with immediate intervention in patients with newly diagnosed carotid or vagal paragangliomas. The study hypothesis is that an initial active surveillance strategy increases the time before functional outcome deterioration, particularly ENT-related symptoms, while not resulting in a higher complication rate when treatment is subsequently performed. Eligible patients will undergo baseline assessment including a specialized ENT examination to evaluate cranial nerve function and cervical MRI (or contrast-enhanced CT when MRI is contraindicated) to confirm tumor location, size, and the absence of lymphadenopathy or atypical imaging features. After providing written informed consent, participants will be centrally randomized in a 1:1 ratio, stratified by study center and tumor location, to either active surveillance or immediate intervention. Patients assigned to active surveillance will undergo regular clinical and radiological follow-up, with treatment initiated only if disease progression or symptom development warrants intervention. Patients assigned to immediate intervention will receive surgery or radiotherapy according to multidisciplinary team recommendations and local practice, within six months after randomization. Patients who decline participation in the randomized trial, as well as those who are not eligible for randomization, may be offered participation in a parallel observational study collecting clinical, imaging, treatment and outcome data according to routine practice. Patient quality of life will also be assessed throughout the study (experimental and observational) using validated questionnaires.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Active follow-up
Patients will be treated by surgery or radiation. The choice between these 2 options is left to the discretion of the investigator and the patient.
Procedure: Surgery · Radiation: Radiation
Patients will not receive any treatment, they will undergo annual follow-up assessments according to the standard of care. Upon disease progression, patients will be allowed to switch to the treatment group.
Patients may be treated with surgery to remove the paraganglioma within 6 months after randomization.
Patients may be treated with radiation within 6 months after randomization.
Time to functional outcome deterioration
Time to functional outcome deterioration is defined as the delay between inclusion and functional outcome deterioration. Patients without functional deterioration are censored at their last functional assessment. Functional outcome deterioration is defined as a decrease in at least 12 points (or 8.6%) of the FACT H\&N score since inclusion. The FACT-H\&N score ranges from 0 to 148. The higher the score, the better the quality of life.
Time frame: From baseline to 5 years maximum
Evolution of the functional outcomes between the groups
Functional outcomes are defined by the overall score of the FACT H\&N in both groups. The FACT-H\&N score ranges from 0 to 148. The higher the score, the better the quality of life.
Time frame: Baseline, 1 year and 5 years
Evolution of the functional outcomes between the groups
Functional outcomes are defined by the overall score of the EORTC QLQ-HN43 in both groups. The scores of the EORTC QLQ-HN43 module are standardized on a scale from 0 to 100. For all symptom scales, a higher score reflects greater symptom burden and poorer quality of life.
Time frame: Baseline, 1 year and 5 years
Quality of life (QoL)
Change on QoL in both groups assessed by the global health status score of the EORTC QLQ-C30. The scores of the EORTC QLQ-C30 questionnaire are standardized on a scale from 0 to 100. A higher score reflects a better level of functioning and a better quality of life.
Time frame: Baseline, 1 year and 5 years
Anxiety
Change on the anxiety evaluation in both groups assessed by HAD scale. The higher the score, the greater the severity of anxiety or depressive symptoms. The total score ranges from 0 to 42.
Time frame: Baseline, 1 year and 5 years
Factors associated with a significant quality of life
Variation of at least 10% of the global health status score of the EORTC QLQ-C30. The scores of the EORTC QLQ-C30 questionnaire are standardized on a scale from 0 to 100. A higher score reflects a better level of functioning and a better quality of life.
Time frame: Baseline, 1 year, 5 years
Factors associated with functional outcomes
Variation of at least 10% of the one of the scales of the QLQ-HN43. The scores of the EORTC QLQ-HN43 module are standardized on a scale from 0 to 100. For all symptom scales, a higher score reflects greater symptom burden and poorer quality of life.
Time frame: Baseline, 1 year, 5 years
Factors associated with anxiety deterioration
Variation of at least 10% of the anxiety scale of HAD. The Hospital Anxiety and Depression Scale (HADS) consists of two subscales including anxiety. Each subscale ranges from 0 to 21, with higher scores reflecting more severe symptomatology.
Time frame: Baseline, 1 year, 5 years
Switch proportion, reason and time to therapeutic intervention
Proportion of patients in the active FU group needing later therapeutic intervention, the reason and the time to therapeutic intervention
Time frame: From baseline to study end
Progression/recurrence rate
Time to progression/recurrence defined as the delay between inclusion and tumor progression in all groups (20% increase in one diameter increase according to RECIST 1.1 criteria, spread metastasis or tumor appearance after total removal). Patients without progression/recurrence will be censored at the last imaging assessment. At least, one assessment will be conducted at 5 years.
Time frame: From baseline to study end
Surgery complication rate
Proportion of all operated patients with complications post-surgery (Clavien-Dindo classification).
Time frame: At 1 year and 5 years
Radiation therapy complication rate
Proportion of all irradiated patients with complications post irradiation (CTCAE V5.0)
Time frame: At 1 year and 5 years
Disease progression
Characterization of spontaneous tumor evolution in patients with active FU
Time frame: At 1 year and 5 years
Proportion of distant metastasis
Characterization of spontaneous tumor evolution in patients with active FU
Time frame: At 5 years
Start is estimated for Oct 2026; primary completion for Oct 2034, 96 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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