NCT05122507

Brief Summary

Prospective study for therapy monitoring of locally advanced and metastatic head and neck cancer patients by detection of circulating tumor nucleic acids in peripheral blood and saliva

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 8, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5.9 years

First QC Date

October 25, 2021

Last Update Submit

April 11, 2023

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

  • Early recurrence detection lead time

    Lead time is defined as time between liquid-biopsy based recurrence detection and clinical recurrence or progression.

    Assessed up to 24 months

Secondary Outcomes (2)

  • Recurrence-free survival

    Assessed up to 24 months

  • Overall survival

    Assessed up to 24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for HNSCC at Klinikum rechts der Isar der Technischen Universität München

You may qualify if:

  • Head and neck squamous cell carcinoma (HNSCC)
  • Written informed consent

You may not qualify if:

  • Neoplasms other than HNSCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der Technischen Universität München

Munich, 81675, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, EDTA blood plasma, serum, saliva

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Irina Kerle, MD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

  • Markus Wirth, MD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

  • Christof Winter, MD, PhD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Wirth, MD

CONTACT

+49 89 4140markus.wirth@tum.de

Christof Winter, MD, PhD

CONTACT

+49 89 4140christof.winter@tum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 16, 2021

Study Start

May 8, 2017

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)