Clinical trial NCT06980740: Video-Tumorboard PLUS
Official title: Video-Tumorboard PLUS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Melanoma
Telemedicine
Keywords: Malignant Melanoma
Telemedicine
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
name: University Hospital, Bonn
name: University Hospital Dresden
First posted: 2025-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As part of the vTB+ study, an evaluation of the video tumor board is to be carried out for as broad a section of the population as possible. Women of childbearing potential with and without contraception make up a relevant proportion of the population. Participation in the study is not associated with physical interventions, so that the contraceptive status of fertile participants is irrelevant. Even in the case of pregnancy, participation in the study would be harmless. The exclusion of women of childbearing potential with and without contraception from the vTB+ study would therefore represent a gender-based disadvantage.

Brief summary: In weekly expert meetings for oncological diagnostics and therapy, known as tumor boards, individual therapy recommendations are developed for cancer patients. By further developing and optimizing the CCCs' video tumor boards, initially using skin cancer as an example, we want to ensure that more patients can benefit from the expertise of several specialist disciplines and innovations - regardless of where they live.


Eligibility criteria: Inclusion Criteria:

* The study includes adult, external patients who, according to the certification requirements of the German Cancer Society, should be presented to the CCCs in a tumor board .

Inclusion criteria for patients:

* Minimum age 18 years
* Consent to participate in the study (signing of patient consent) should be presented in vTB+ according to the doctor, based on the disease/diagnosis, especially in the case of:

  * Malignant melanoma from stage IIB
  * Malignant melanoma and stage shift/recurrence o Extracutaneous melanoma o Cutaneous lymphoma from stage Ib o Problem cases with malignant, epithelial tumors (BCC, SCC) with interdisciplinary issues, e.g. complicated localization, extension/ infiltration (e.g. Ulcus rodens, Ulcus terebrans), metastasized tumors, immunosuppressed patients o all rare malignant skin tumors (including Merkel cell carcinoma, DFSP, MFH, leiomyosarcoma, S., Kaposi's sarcoma, angiosarcoma), regardless of stage o severe side effects from drug-based tumor therapy • is an external patient: An external patient is someone who receives tumor therapy exclusively or in co-treatment in the branch or in an external clinic (in distinction to patients without prior treatment for initial presentation at the CCC) . This also applies to patients who are only seen once at the vTB.

In this case, revenue/cost aspects and the DKG requirement are ignored. This means that so-called external patients can also be treated at the center, including initiation of therapy. The decisive factor is the presentation of the external patient (personal presentation of the external patients is not mandatory) and that external co-treaters are consistently informed and involved.

Inclusion criteria for external doctors:

* has a medical license
* has dermatological patients who are eligible to be presented in the vTB+

Exclusion Criteria:

Patients will be excluded from the study if they meet the following criteria:

* Linguistic or other limitations (such as dementia) that prevent independent consent to the privacy policy.
* No consent to participate in the study (patient consent) or withdrawal of consent during the course of the study In addition, external physicians will be excluded from the study if no joint cooperation agreement can be negotiated and signed.

Primary outcomes:
measure: Presentation of external patients in the video-tumorboard
timeFrame: Day 365
Secondary outcomes:
measure: Increase in the proportion of external patients invited to a clinical study
timeFrame: Day 365
measure: Adherence to tumorboard recommendations for external patients
timeFrame: Up to two weeks after inclusion
measure: Offer of supportive therapies by the comprehensive cancer center
timeFrame: Up to two days after inclusion
measure: Duration of the transmission of the tumorboard recommendations
timeFrame: Up to two weeks after inclusion
measure: "Time to integration" into palliative care
timeFrame: Once per patient within two weeks after transmission of the tumorboard recommendation if applicable
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Abteilung für Integrierte Onkologie - CIO Bonn, Universitätsklinikum Bonn
city: Dresden
country: Germany
facility: Nationales Centrum für Tumorerkrankungen Klinik u. Poliklinik für Dermatologie, Universitätsklinikum Dresden
city: Münster
country: Germany
facility: Westdeutsches Tumorzentrum Münster, Universitätsklinikum Münster
Study officials:
affiliation: Westdeutsches Tumorzentrum Münster, Universitätsklinikum Münster
name: Philipp Lenz, MD
role: PRINCIPAL_INVESTIGATOR
References: