NCT07571499

Brief Summary

TRANSCEND-XR is a European research project designed to better support adolescents and young adults who have been cured of testicular cancer. Even after treatment has ended, many young people continue to face physical, psychological, or social difficulties that are often poorly understood and insufficiently addressed. The project aims to develop an innovative digital tool using extended reality (XR) to help these young people better understand the potential long-term effects of the disease and its treatments, recognize signs that require medical attention, and become more active participants in their own health follow-up. TRANSCEND-XR first includes a pilot phase to test feasibility and improve the tool, followed by a larger clinical study comparing its use with usual medical follow-up. Researchers will assess, in particular, its impact on patients' knowledge, quality of life, and ability to seek help. The ultimate goal is to sustainably improve information, autonomy, and well-being among young survivors of testicular cancer through a digital approach tailored to their needs and daily practices.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

January 4, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 23, 2026

Last Update Submit

April 30, 2026

Conditions

Testicular CancerTestis CancerAYA Cancer SurvivorsSurvivor Patients

Keywords

Testicular cancer survivorsAdolescents and young adults (AYA)Survivorship careSupportive care needsLate effects of cancer treatmentPost-cancer follow-upQuality of lifePatient educationExtended reality (XR)Virtual reality in healthcareDigital health interventionImmersive digital toolsLong-term cancer effects

Outcome Measures

Primary Outcomes (2)

  • Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer

    Assessed by inclusion time, engagement, no major issue with patient feedback

    after 6 months of inclusion

  • pRCT (Pragmatic Randomized Controlled Trial): knowledge of the late effects of XR digital tool in AYA survivors of testicular cancer

    Assessed by analysis of data collected during study visits

    12 months follow-up (18 months after randomization)

Secondary Outcomes (3)

  • Pilot study: quality of questionnaires used

    9 months after the begin of the study

  • pRCT (Pragmatic Randomized Controlled Trial): Health-related quality of life

    at the end of the study (5 years)

  • pRCT (Pragmatic Randomized Controlled Trial): Supportive care needs

    at the end of the study (5 years)

Study Arms (2)

Intervention arm (arm I)

EXPERIMENTAL

participants will receive, in addition to their standard of care, an educational intervention via the digital tool for a period of 6 months, followed by an additional 12 months of follow-up.

Other: Digital tool using extended reality

Control arm (arm C)

NO INTERVENTION

participants will receive their standard of care, without intervention, for a period of 6 months, followed by an additional 12 months of follow-up.

Interventions

Digital tool using extended realityOTHER

TRANSCEND-XR is a digital educational intervention based on extended reality (XR), designed for adolescents and young adults who have completed curative treatment for testicular cancer. It provides interactive and immersive content aimed at improving understanding of the late effects of treatment, whether physical, psychological, or social. The tool helps users recognize symptoms that require medical attention, strengthen their health knowledge, and adopt behaviors that support long-term follow-up, such as self-examination and appropriate use of healthcare services. Co-designed with patients and healthcare professionals, TRANSCEND-XR aims to enhance autonomy, confidence, and engagement of young survivors in managing their health after cancer.

Intervention arm (arm I)

Eligibility Criteria

Age15 Years - 39 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAny person assigned male at birth who is diagnosed with stage I-III TC (germ cell tumour of the testicles).
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any person assigned male at birth who is diagnosed with stage I-III TC (germ cell tumour of the testicles).
  • Completed curative treatment comprising of at least one standard treatment modality (surgery, chemotherapy and/or radiotherapy) for treatment of their cancer. A maximum of 9 months from the end of curative treatment will be allowed.
  • Permitted treatment modalities:
  • Localised disease: orchiectomy with or without chemotherapy and/or radiotherapy.
  • Metastatic disease: orchiectomy and chemotherapy or radiotherapy or retroperitoneal surgery, or a combination of aforementioned treatments. First-line treatment only allowed.
  • Willing and able to provide a valid and signed informed consent and/or assent, as appropriate.
  • ECOG performance status 0-2.
  • Patients accept to use personal smartphone
  • Patients able to read and understand the local language

You may not qualify if:

  • Non-testicular germ cell tumours (e.g., mediastinal primary or retroperitoneal primary tumours).
  • Non-germ cell TC.
  • Previous chemotherapy, radiotherapy, or surgery for TC other than that allowed in IC 4.
  • History of contralateral TC.
  • Any illness that would prevent the AYA TC survivor from giving a valid and signed informed consent, as assessed by the investigator.
  • Any illness that might be exacerbated by the use of an XR digital tool, as assessed by the investigator, including history of severe motion sickness, brain lesions and epilepsy.
  • Uncontrolled medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease (including but not limited to grade 2 or higher cardiac failure, arrythmia, unstable angina, history of myocardial infract in the 6 months which, in the opinion of the treating physician, would influence the assessment of long-term side effect of TC treatment.
  • AYA TC survivors with a "currently active" second malignancy other than non-melanoma skin cancers, superficial non-invasive (pTa or pTis) TCC of the bladder, or intratubular germ cell neoplasia. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
  • Chemotherapy or radiotherapy for malignant disease other than TC within the past 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Study Officials

  • Anna Patrikidou

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Patrikidou

CONTACT

+33142114211anna.patrikidou@gustaveroussy.fr

Adeline Salasc

CONTACT

adeline.salasc@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: TRANSCEND-XR is an international clinical study conducted in two phases. It begins with a non-randomized pilot study aimed at assessing feasibility and optimizing the extended reality digital tool. It is followed by a pragmatic randomized controlled trial comparing two groups: one group receiving usual medical follow-up with the TRANSCEND-XR tool, one group receiving usual medical follow-up alone. The study evaluates the impact of the tool under conditions close to real-world clinical practice among adolescents and young adults who have survived testicular cancer.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 6, 2026

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04