Sample Size for Multivariate Time-to-event Data | NCT03964402

Studies
Sample Size for Multivariate Time-to-event Data

NCT03964402

Sponsor

Institut Bergonié

Status

Completed

Last Update Posted

Sep 17, 2025Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Clinical Trials

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2025

Last Update Posted Date

Sep 17, 2025Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Usually, one assumes that populations are homogeneous within each treatment arm, that is, within each arm, (i) the baseline risk is identical for all patients, and (ii) the treatment effect is identical for all patients. This assumption however may not hold in all circumstances. This project aims at providing a statistical method for the estimation of sample size in RCT, in the presence of heterogenous populations, such as assuming populations with distinct underlying baseline risks or assuming different treatment effects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinical trial		Corresponds to a comparative clinical trial for which our new statistical methods will be applied to estimate sample size

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	time from randomization to death	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Any comparative clinical trial for which modern statistical methods are required to estimate sample size

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any comparative clinical trial for which modern statistical methods are required to estimate sample size, in particular, it can be clinical trials :

with heterogeneous populations,
with recurrent event data,
involving a biomarker-Strategy Designs With Multiple Treatments.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carine Bellera, PhD	Institut Bergonié	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Bergonié, Comprehensive Cancer Center		Bordeaux		33400	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34242412	Background	Dinart D, Bellera C, Rondeau V. Sample size estimation for cancer randomized trials in the presence of heterogeneous populations. Biometrics. 2022 Dec;78(4):1662-1673. doi: 10.1111/biom.13527. Epub 2021 Sep 3.
38334044	Background	Dinart D, Bellera C, Rondeau V. Sample size estimation for recurrent event data using multifrailty and multilevel survival models. J Biopharm Stat. 2025 Mar;35(2):241-256. doi: 10.1080/10543406.2024.2310306. Epub 2024 Feb 9.