NCT05500391

Brief 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 conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
75mo left

Started Feb 2024

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2024Jul 2032

First Submitted

Initial submission to the registry

August 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

August 10, 2022

Last Update Submit

March 16, 2026

Conditions

Stage I Testicular SeminomaStage I Testicular Nonseminomatous Germ Cell TumorGastrointestinal Stromal TumorsOvarian Germ Cell TumorAdenocarcinoma, Clear CellBorderline Ovarian TumorSex Cord-Stromal TumorMucinous Adenocarcinoma of OvaryCarcinoma, Small CellCarcinosarcoma, OvarianSerous Tumor of OvaryGliomaNeuroendocrine TumorsAggressive Fibromatosis of Abdominal Wall (Disorder)

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (7)

  • 5-year compliance to the customized surveillance plan

    5 years

  • Drop-out rate

    5 years

  • Description of the use of care

    5 years

  • Occurrence and management of oncological events

    5 years

  • Progression-free survival

    5 years

  • +2 more secondary outcomes

Other Outcomes (5)

  • Costs in terms of medical transport use

    5 years

  • Salary mass mobilized from a hospital perspective in both arms

    5 years

  • Patient satisfaction

    2 years

  • +2 more other outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Telesurveillance by a nurse

Other: Oncological Follow-up

Control

OTHER

On-site surveillance by a hospital physician

Other: Oncological Follow-up

Interventions

Oncological Follow-upOTHER

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

ControlExperimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • Contraindication to imaging tests required for the surveillance plan
  • No telephone
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens

Amiens, 80054, France

NOT YET RECRUITING

Centre François Baclesse

Caen, 14076, France

NOT YET RECRUITING

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20429948BACKGROUND

  • Moloney 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.

    PMID: 31280494BACKGROUND

  • Martin 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.

    PMID: 30093916BACKGROUND

  • Keshava 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.

    PMID: 34922758BACKGROUND

  • Ferrua 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.

    PMID: 32429987BACKGROUND

MeSH Terms

Conditions

SeminomaGastrointestinal Stromal TumorsAdenocarcinoma, Clear CellSex Cord-Gonadal Stromal TumorsCarcinoma, Small CellCarcinosarcomaGliomaNeuroendocrine Tumors

Condition Hierarchy (Ancestors)

GerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Gonadal TissueNeoplasms, Complex and MixedSarcomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Nerve Tissue

Study Officials

  • PENEL Nicolas, MD, PhD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence ROTSAERT

CONTACT

0320295860 / 0320295918l-rotsaert@o-lambret.fr

Fanny BEN OUNE

CONTACT

0320295918f-benoune@o-lambret.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 15, 2022

Study Start

February 28, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

July 1, 2032

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(3)