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Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer (ROOCT)

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ClinicalTrials.gov Identifier: NCT04610645
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
Verein zur Forschungsförderung der Krebshilfe OÖ
RECENDT GmbH
Johannes Kepler Universität Linz, Abteilung FLLL
Universitätsklinikum Erlangen
Information provided by (Responsible Party):
Hans Geinitz, Krankenhaus Barmherzige Schwestern Linz

Study Description
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Brief Summary:
The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

Condition or disease Intervention/treatment
Head and Neck Cancer Radiotherapy Device: OCT Device: Dermatoscope Genetic: 3-Colour FISH

Detailed Description:
Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H&N 43). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 8, 2026
Estimated Study Completion Date : December 8, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Head and Neck Cancer Patients
Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
 Device: OCT
3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck
Other Name: Lumedica OQlabscope 2.0

Device: Dermatoscope
2x2 pictures taken with a dermatoscope
Other Name: Heine iC1 Set/6

Genetic: 3-Colour FISH
Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual
Other Name: Fluorescent In Situ Hybridisation


Outcome Measures
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Primary Outcome Measures :
  1. early radiation induced skin structure changes detected in OCT [ Time Frame: First week of radiation therapy ]
    any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)


Secondary Outcome Measures :
  1. detection of any skin strucure changes with OCT during the course of RT [ Time Frame: weeks 1 - 6 of radiation therapy ]
    any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

  2. Correlation of OCT changes with clinical appearent acute side effetcs [ Time Frame: weeks 1 - 6 of radiation therapy ]
    Correlation of OCT changes with CTC radiation toxicity

  3. Correlation of OCT changes with clinical appearent late side effetcs [ Time Frame: 1 year post-RT ]
    Correlation of OCT changes with CTC radiation toxicity

  4. Correlation of OCT changes with radiation sensitivity [ Time Frame: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT ]
    Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

  5. Correlation of OCT changes with dermatoscopic skin appearance [ Time Frame: weeks 1-6 of RT ]
    Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

  6. Correlation of quality of live with OCT and radiation sensitivity [ Time Frame: weeks 1-6 of RT, 6 weeks and 1 year post-RT ]
    Correlation of quality of live as measured with the EORT QLC C30 and Head and neck module H&N 43 with OCT and radiation sensitivity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern
Criteria

Inclusion Criteria:

  • Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy

Exclusion Criteria:

  • reduced mental capacity
  • treatment with C225 Cetuximab
  • bearded patients
  • overt skin disease
  • vast tattoos in the neck region
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610645


Contacts
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Contact: Elisabeth Silberberger, MSc +43 (732) 7677 ext 6484 elisabeth.silberberger@ordensklinikum.at
Contact: Hans Geinitz, Prim. Univ.-Prof. Dr. +43 (732) 7677 ext 6938 hans.geinitz@ordensklinikum.at

Locations
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Austria
Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Elisabeth Silberberger, MSC    +43 (732) 7677 ext 6484    elisabeth.silberberger@ordensklinikum.at   
Contact: Hans Geinitz, Prim. Univ.-Prof. Dr.    +43 (732) 7677 ext 6938    hans.geinitz@ordensklinikum.at   
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
Verein zur Forschungsförderung der Krebshilfe OÖ
RECENDT GmbH
Johannes Kepler Universität Linz, Abteilung FLLL
Universitätsklinikum Erlangen
Investigators
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Principal Investigator: Hans Geinitz, Prim. Univ.-Prof. Dr. Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)
More Information
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Responsible Party: Hans Geinitz, Prim. Univ.-Prof. Dr., Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT04610645    
Other Study ID Numbers: EKS 39/18
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Geinitz, Krankenhaus Barmherzige Schwestern Linz:
Optical coherence tomography
OCT
Head and neck cancer
radiotherapy
radiation therapy
skin toxicity
 radiation sensitivity
FISH
Quality of Life
EORTC QLQ C30
EORTC H&N 43
Radiochemotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms