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| Name | Class |
|---|---|
| Verein zur Forschungsförderung der Krebshilfe OÖ | UNKNOWN |
| RECENDT GmbH | UNKNOWN |
| Johannes Kepler Universität Linz, Abteilung FLLL | UNKNOWN |
| Universitätsklinikum Erlangen |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and Neck Cancer Patients | Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT | Device | 3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck |
|
| Measure | Description | Time Frame |
|---|---|---|
| early radiation induced skin structure changes detected in OCT | any reproducible difference in skin OCT appearance as compared with baseline (pre-RT) | First week of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| detection of any skin strucure changes with OCT during the course of RT | any reproducible difference in skin OCT appearance as compared with baseline (pre-RT) | weeks 1 - 6 of radiation therapy |
| Correlation of OCT changes with clinical appearent acute side effetcs |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern
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| Name | Affiliation | Role |
|---|---|---|
| Hans Geinitz, Prim. Univ.-Prof. Dr. | Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | Upper Austria | 4010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40548163 | Result | Heise B, Schlagnitweit P, Pollak R, Felbermayer K, Silberberger E, Kocik L, Trinkl L, Weinzinger D, Anderlik P, Springer A, Geroldinger-Simic M, Gruber G, Hartl M, Geinitz H. Monitoring of Early Skin Reactions by Optical Coherence Tomography and Dermatoscopy in Patients Receiving Radiation Therapy for Head and Neck Cancer. Adv Radiat Oncol. 2025 Jun 10;10(7):101793. doi: 10.1016/j.adro.2025.101793. eCollection 2025 Jul. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2018 | Jul 22, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| UNKNOWN |
| Andreas Fahl Medizintechnik-Vertrieb GmbH | UNKNOWN |
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| Dermatoscope | Device | 2x2 pictures taken with a dermatoscope |
|
|
Correlation of OCT changes with CTC radiation toxicity |
| weeks 1 - 6 of radiation therapy |
| Correlation of OCT changes with clinical appearent late side effetcs | Correlation of OCT changes with CTC radiation toxicity | 1 year post-RT |
| Correlation of OCT changes with radiation sensitivity | Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH) | OCT: weeks 1-6 of radiation therapy; FISH: pre-RT |
| Correlation of OCT changes with dermatoscopic skin appearance | Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy | weeks 1-6 of RT |
| Correlation of quality of live with OCT and radiation sensitivity | 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 | weeks 1-6 of RT, 6 weeks and 1 year post-RT |