Malignant MelanomavTB+NCT06980740
Video-Tumorboard PLUS
An observational study of Malignant Melanoma and Telemedicine, run by University Hospital Muenster at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Telemedicine
- How many people
- 300 participants
- Where
- 3 sitesGermany
- Study dates
- 1 May 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 .
- 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.
- has a medical license
- has dermatological patients who are eligible to be presented in the vTB+
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Abteilung für Integrierte Onkologie - CIO Bonn, Universitätsklinikum Bonn
Bonn, 53127
Ingo Schmidt-Wolf, MD, +49 228 28717033, ingo.schmidt-wolf@ukbonn.de
- Recruiting
Nationales Centrum für Tumorerkrankungen Klinik u. Poliklinik für Dermatologie, Universitätsklinikum Dresden
Dresden, 01099
Friedegund Meier, MD, +49 351 4583677, friedegund.meier@ukdd.de
- Not yet recruiting
Westdeutsches Tumorzentrum Münster, Universitätsklinikum Münster
Münster, 48149
Philipp Lenz, MD, +49 251 83 43745, philipp.lenz@ukmuenster.de
About this study
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.
- Conditions
- Malignant Melanoma, Telemedicine
- Keywords
- Malignant Melanoma, Telemedicine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Retrospective | |
| 2 | Prospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presentation of external patients in the video-tumorboard
Increase in the proportion of external patients in the video-tumorboard
Measured: Day 365
Secondary outcomes (5)
Increase in the proportion of external patients invited to a clinical study
Increase in the proportion of external patients in clinical studies
Measured: Day 365
Adherence to tumorboard recommendations for external patients
Proportion of implemented tumorboard recommendations for external patients
Measured: Up to two weeks after inclusion
Offer of supportive therapies by the comprehensive cancer center
Proportion of (external) patients who are offered at least one supportive therapy (e.g. psychooncology) within the video-tumorboard
Measured: Up to two days after inclusion
Duration of the transmission of the tumorboard recommendations
Duration of the transmission of the tumorboard recommendations
Measured: Up to two weeks after inclusion
"Time to integration" into palliative care
Time between medical recommendation for palliative care and first contact with palliative care
Measured: Once per patient within two weeks after transmission of the tumorboard recommendation if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), University Hospital, Bonn, University Hospital Dresden
- Responsible party
- Sponsor
- Investigators
- Philipp Lenz, MD, Principal investigator, Westdeutsches Tumorzentrum Münster, Universitätsklinikum Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980740
- Sponsor's protocol ID
- BO ff (Multi)-EK-16012025
- Other IDs
- 2025-275-b-S
- Acronym
- vTB+
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Tumorboard PLUS
- ClinicalTrials.gov ID
- NCT06980740
- Acronym / sponsor ID
- vTB+ / BO ff (Multi)-EK-16012025
- Conditions
- Malignant Melanoma, Telemedicine
- Keywords
- Malignant Melanoma, Telemedicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), University Hospital, Bonn, University Hospital Dresden
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Retrospective |
| 2 | – | –Prospective |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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 .
- 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:
- 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.
- has a medical license
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presentation of external patients in the video-tumorboard
Time frame: Day 365
Increase in the proportion of external patients in the video-tumorboard
5 secondary outcomes
Increase in the proportion of external patients invited to a clinical study
Time frame: Day 365
Adherence to tumorboard recommendations for external patients
Time frame: Up to two weeks after inclusion
Offer of supportive therapies by the comprehensive cancer center
Time frame: Up to two days after inclusion
Duration of the transmission of the tumorboard recommendations
Time frame: Up to two weeks after inclusion
"Time to integration" into palliative care
Time frame: Once per patient within two weeks after transmission of the tumorboard recommendation if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Lenz, MD principal investigator
Westdeutsches Tumorzentrum Münster, Universitätsklinikum Münster
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma and Telemedicine, run by University Hospital Muenster at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Lenz, MD (+49 251 83 43745, philipp.lenz@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presentation of external patients in the video-tumorboard (time frame: Day 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.