NCT06807034

Brief Summary

to characterise the impact of microbiota in radiotherapy efficacy

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 head-and-neck-cancer

Timeline
8mo left

Started Nov 2024

Typical duration for phase_4 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
active not 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 Progress68%
Nov 2024Jan 2027

Study Start

First participant enrolled

November 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2027

Expected
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 20, 2025

Last Update Submit

January 31, 2025

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Microbiota

    Analysis of buccal microbiota by 16SrRNA gene sequencing

    2 years

Study Arms (1)

buccal swabs

EXPERIMENTAL

buccal swabs for microbiota analysis before and after treatment

Other: buccal swabs

Interventions

buccal swabsOTHER

buccal swabs for microbiota analysis before and after radiotherapy

buccal swabs

Eligibility Criteria

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

You may qualify if:

  • head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICAP

Avignon, 84918, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 4, 2025

Study Start

November 18, 2024

Primary Completion

January 20, 2026

Study Completion (Estimated)

January 20, 2027

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)