CancerPhase 3RC-102NCT06867705
Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
A Phase 3 study testing Resilience PRO in people with Cancer, run by Resilience at 36 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Resilience PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,458 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 1 Apr 2025to Dec 2029
- Phase
- Phase 3
- 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
- Age: Adults ≥ 18 years.
- Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.
- Diagnosis: Patients with cancer at any stage.
- Systemic Treatment
- Remote Monitoring Eligibility: Access to a smartphone
- Language: Ability to understand and communicate in the language(s) in which the trial is conducted.
Who cannot join
- Age: Patients under 18 years of age.
- Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.
- Concurrent remote monitoring
- HSCT or CAR-T Therapy
- Cognitive Impairment
- Pregnancy or breastfeeding
- Subject under administrative or judicial control
Trial locations and contacts
36 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 2 countries
France26 sites, 26 recruiting
- Recruiting
Hôpital Privé de Provence
Aix-en-Provence, 13080
Salima DELLYS, +33.(0)4.84.49.60.43, s.dellys@hpp13.com
- Recruiting
Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13100
Nabila Akkache, +33.(0)4.42.33.50.46, nakkache@ch-aix.fr
- Recruiting
Centre Hospitalier Henri Mondor-Aurillac
Aurillac, 15000
Manon MONCET, +33 (0)4 71 46 56 00, m.moncet@ch-aurillac.fr
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64100
Emmanuelle Vignes, +33.(0)5.59.44.37.62, evignes@ch-cotebasque.fr
- Recruiting
Centre Hospitalier Universitaire de Caen Normandie
Caen, 14033
Justine Lecache, +33.(0)2.31.06.20.10, lecache-j@chu-caen.fr
- Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003
Céline Bonhomme, +33.(0)4.73.75.00.74, cbonhomme@chu-clermontferrand.fr
- Recruiting
Centre Hospitalier Universitaire Grenoble - Alpes
La Tronche, 38700
Amandine Ramond, +33.(0)4.76.76.57.55, aramond@chu-grenoble.fr
- Recruiting
GHICL Hôpital Saint Vincent de Paul
Lille, 59000
Catherine CUNISSE, +33.(0)3.20.87.45.32, Cunisse.Catherine@ghicl.net
- Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59037
Jeremy DRUGEON, +33.(0)3.20.44.54.61, Jeremy.DRUGEON@chu-lille.fr
- Recruiting
Hôpital Privé Jean Mermoz - Institut de Cancérologie
Lyon, 69008
Gaëlle Le Guludec, +33 (0)4 37 53 87 26, gaelle.leguludec@ramsaysante.fr
- Recruiting
AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone
Marseille, 13005
Nathalie Moureau, +33 (0)4 91 38 73 77, nathalie.moureau@ap-hm.fr
- Recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Celine LEREBOURG, +33.(0)2.40.16.59.30, celine.lerebourg@chu-nantes.fr
- Recruiting
Hôpital Privé du Confluent
Nantes, 44200
Emma CADET, +33 (0) 02 28 25 56 87, ECADET@vivalto-sante.com
- Recruiting
Centre Hospitalier Universitaire de Nice
Nice, 06000
Enora Valle, +33 (0)4 92 03 82 80, enora.valle@hospigrandouest.fr
- Recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
Shanice Roriz, +33 (0)4 66 68 33 01, shanice.roriz@chu-nimes.fr
- Recruiting
AP-HP Hôpitaux Universitaires La Pitié Salpêtrière
Paris, 75013
Direction de la Recherche Clinique et de l'Innovation, +33 (0)1 42 16 03 81, promotion-externe-industrielle.drc@aphp.fr
- Recruiting
Clinique Mutualiste Bretagne Occidentale
Quimper, 29000
Karine Mas, +33 (0)2 57 23 05 68, karine.mas@hospigrandouest.fr
- Recruiting
Hôpital Privé de la Loire (HPL) - Saint Etienne
Saint-Etienne, 42100
Sandy MESSAOUDENE, +33 (0)4 77 42 29 51, sandy.messaoudene@ramsaysante.fr
- Recruiting
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606
Enora Valle, +33.(0)2.72.27.53.34, enora.valle@hospigrandouest.fr
- Recruiting
Centre Hospitalier Universitaire Sud Réunion
Saint-Pierre, 97448
Sara MIKOLASEK, +262 (0)2 62 35 90 00, sara.mikolasek@chu-reunion.fr
- Recruiting
Centre Clinical Elsan
Soyaux, 16800
Corine Bustreau, +33 (0)5 45 69 68 32, corine.bustreau@elsan.care
- Recruiting
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, 83056
Charline Genin, +33.(0)4.94.14.52.90, charline.genin@ch-toulon.fr
- Recruiting
Clinique Pasteur
Toulouse, 31076
Sophie Bringer, +33.(0)5.67.20.44.01, sbringer@groupeorion.fr
- Recruiting
Centre de Cancérologie Les Dentellières
Valenciennes, 59300
Stéphanie Vermoesen, +33.(0)3.66.22.70.54, svermoesen@lesdentellieres.com
- Recruiting
Clinique Teissier
Valenciennes, 59300
Marielle Fery, +33 (0)3 27 14 24 34, mfery@ahnac.com
- Recruiting
Gustave Roussy
Villejuif, 94805
Sabrina Ikene, +33.(0)1.42.11.40.53, Sabrina.IKENE@gustaveroussy.fr
Germany10 sites, 10 recruiting
- Recruiting
University Hospital Augsburg - UKA
Augsburg, 86156
Marina GUDI, marina.gudi@uk-augsburg.de
- Recruiting
Helios Klinikum Bad Saarow
Bad Saarow, 15526
Simone MICHEEL, simone.micheel@helios-gesundheit.de
- Recruiting
Katholisches Klinikum Bochum UK St. Josef - Hospital
Bochum, 44791
Meike MOHR, +49 (0)234 509-2365, meike.mohr@klinikum-bochum.de
- Recruiting
UK Hamburg- Eppendorf (UKE)
Hamburg, 20246
Carlotta Evers, c.evers@uke.de
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Abirami Kaliyaperumal, +49 511 532-4077, Kaliyaperumal.Abirami@mh-hannover.de
- Recruiting
MVZ Aschaffenburg-Alzenau
Hösbach, 63768
Nicole SEMMLER-LINS, nicole.semmler-lins@mvz-klinikum-ab.de
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel
Kiel, 24105
Emilia Prieß, +49 (0) 451 500 -44355, Emilia.Priess@uksh.de
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
Lübeck, 23538
Emilia Prieß, +49 (0) 451 500 -44355, Emilia.Priess@uksh.de
- Recruiting
Onkomedeor MVZ Perlach
München, 81737
Manuela HEINEMANN, manuela.heinemann@onko-medeor.de
- Recruiting
Universitätsklinikum Tuebingen
Tübingen, 72076
Marianne KRAUS, marianne.kraus@med.uni-tuebingen.de
About this study
Official title: Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)
The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment.
The main question it aims to answer is:
Read more
- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.
Read the detailed description
Resilience PRO is a digital medical device (dMD CE marked, class IIa) that enables the remote monitoring of patients diagnosed with cancer receiving anticancer systemic therapy. Resilience PRO has been positively evaluated by the French health authorities (HAS, Haute Autorité de Santé) and is registered on the French LATM list (Liste des Activités de Télésurveillance Médicale).
Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:
- Step 1. Collection of ePRO
- Step 2. Intelligent analysis and alerts
- Step 3. Adapted care
- Conditions
- Cancer
- Being tested
- Resilience PRO
- Keywords
- Remote Patient Monitoring, Remote Symptom Monitoring, Digital medicine, Resilience PRO, Resilience, PRO, Patient-reported Outcomes
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience PRODevice
The patient will use Resilience PRO remote symptoms monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Remote Symptoms Monitoring with Resilience PRO | Experimental | Resilience PRO will be added on top of conventional care Receives: Device: Resilience PRO |
| Usual care without Remote Symptoms Monitoring | No intervention | Conventional care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related quality of life
EORTC QLQ-C30
Measured: 3 months
Secondary outcomes (2)
Health-economic evaluation
The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.
Measured: 12 months
Overall survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resilience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UNICANCER, Sanoia
- Responsible party
- Sponsor
- Investigators
- Florian Scotté, MD, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867705
- Sponsor's protocol ID
- RC-102
- Other IDs
- 2024-A01584-43 (ID RCB), N° Eudamed: CIV-25-01-050834
- Acronym
- RC-102
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)
- ClinicalTrials.gov ID
- NCT06867705
- Acronym / sponsor ID
- RC-102 / RC-102
- Conditions
- Cancer
- Keywords
- Remote Patient Monitoring, Remote Symptom Monitoring, Digital medicine, Resilience PRO, Resilience, PRO, Patient-reported Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,458 participants (estimated)
- Lead sponsor
- ResilienceIndustry (pharma, biotech, devices)
- Collaborators
- UNICANCER, Sanoia
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Mar 2025 (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.
The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment.
The main question it aims to answer is:
- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.
Detailed description
Resilience PRO is a digital medical device (dMD CE marked, class IIa) that enables the remote monitoring of patients diagnosed with cancer receiving anticancer systemic therapy. Resilience PRO has been positively evaluated by the French health authorities (HAS, Haute Autorité de Santé) and is registered on the French LATM list (Liste des Activités de Télésurveillance Médicale).
Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:
- Step 1. Collection of ePRO
- Step 2. Intelligent analysis and alerts
- Step 3. Adapted care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Symptoms Monitoring with Resilience PRO | Experimental | Device: Resilience PROResilience PRO will be added on top of conventional care |
| Usual care without Remote Symptoms Monitoring | No intervention | –Conventional care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Adults ≥ 18 years.
- Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.
- Diagnosis: Patients with cancer at any stage.
- Systemic Treatment
- Remote Monitoring Eligibility: Access to a smartphone
Key exclusion criteria (7 listed)
- Age: Patients under 18 years of age.
- Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.
- Concurrent remote monitoring
- HSCT or CAR-T Therapy
- Cognitive Impairment
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 |
|---|---|---|
| Resilience PROThe patient will use Resilience PRO remote symptoms monitoring. | Device | Remote Symptoms Monitoring with Resilience PRO |
Primary outcome
Health-Related quality of life
Time frame: 3 months
EORTC QLQ-C30
2 secondary outcomes
Health-economic evaluation
Time frame: 12 months
Overall survival
Time frame: 36 months
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 3 Apr 2026.
- EUDAMED - European Database on Medical DevicesLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Florian Scotté, MD, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resilience PRO in people with Cancer, run by Resilience at 36 sites in 2 countries.
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 6 inclusion and 7 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Resilience (+33 805 69 65 61, support@resilience.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related quality of life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.