Cutaneous MelanomaNCT05675709

Enhancing Skin Cancer Early Detection and Treatment in Primary Care

A study testing Training and Education in people with Cutaneous Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cutaneous Melanoma
What is being tested?: Training and Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 25 Apr 2023to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Clinicians at two Oregon Health \& Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention
Clinicians at the two clinics who do not receive the intervention will serve as study comparators
These individuals are all aged 18 years or older
All practice members speak English

Who cannot join

No one will be intentionally excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Skin cancer screening may help find melanoma sooner, when it may be easier to treat. If found early melanoma and other types of skin cancer may be curable. Multi-component education may be an effective method to help primary care physicians (PCPs) learn about skin cancer screening. This clinical trial examines whether a clinician-focused educational intervention can improve PCP's knowledge and clinical performance to identify and triage skin cancer. This intervention may increase the PCP's ability to diagnose, treat and/or triage early-stage melanoma.

Read the detailed description

PRIMARY OBJECTIVE:

Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer.

OUTLINE:

Participants are assigned to 1 of 2 groups.

PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.

PCPs at the two clinics who do not receive the group training will serve as study comparators.

Conditions: Cutaneous Melanoma
Being tested: Training and Education
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Training and EducationBehavioural
Undergo group trainings

Study groups in NCT05675709
Study group	Role	What they receive
Comparison group	No intervention	PCPs at the two clinics who do not receive the group training will serve as study comparators.
Other, Pragmatic	Experimental	PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. Receives: Behavioral: Training and Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinician Knowledge in Melanoma Risk and Lesion Identification
KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training.
Measured: Immediately before and after the training session
Dermatology Referral
Mean percent of dermatology referrals per 1000 patients
Measured: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.
Use of Dermatology E-consults
number of dermatology e-consults
Measured: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202330 Jun 2024

First posted9 Jan 2023
Study start25 Apr 2023
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05675709
Sponsor's protocol ID: STUDY00024809
Other IDs: NCI-2022-09484, STUDY00024809, P50CA244289
Status last verified: Jun 2025
First submitted: 29 Dec 2022
Last updated: 8 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan is needed

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

All Cutaneous Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Skin Cancer Early Detection and Treatment in Primary Care
ClinicalTrials.gov ID: NCT05675709
Acronym / sponsor ID: STUDY00024809
Conditions: Cutaneous Melanoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: Oregon Health and Science University, National Cancer Institute (NCI)
Study start: 25 Apr 2023 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 9 Jan 2023 (actual)
Results: Posted 8 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer.

OUTLINE:

Participants are assigned to 1 of 2 groups.

PCPs at the two clinics who do not receive the group training will serve as study comparators.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Comparison group	No intervention	–PCPs at the two clinics who do not receive the group training will serve as study comparators.
Other, Pragmatic	Experimental	Behavioral: Training and EducationPCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinicians at two Oregon Health \& Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention
Clinicians at the two clinics who do not receive the intervention will serve as study comparators
These individuals are all aged 18 years or older
All practice members speak English

Key exclusion criteria (1 listed)

No one will be intentionally excluded

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Training and EducationUndergo group trainings	Behavioural	Other, Pragmatic

Primary outcome

Change in Clinician Knowledge in Melanoma Risk and Lesion Identification
Time frame: Immediately before and after the training session
KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training.
Dermatology Referral
Time frame: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.
Mean percent of dermatology referrals per 1000 patients
Use of Dermatology E-consults
Time frame: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.
number of dermatology e-consults

Results and safety

Results posted to the registry on 8 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melanoma Training Group	17	15
Comparison Group	37	29

Primary outcome: Change in Clinician Knowledge in Melanoma Risk and Lesion Identification

Time frame: Immediately before and after the training session. Mean (Standard Deviation). Unit: score on a scale

Measure	Comparison group n = 0	Training group n = 10
Immediately before the training	–	72.1 (7.2)
Immediately after the training	–	80.8 (9.6)

Training group: p = 0.05, paired t-test

Population analysed: Knowledge was assessed before and after the training session for those clinicians who attended the training. We conducted a paired t-test

Primary outcome: Dermatology Referral

Time frame: minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training.. Mean (Standard Deviation). Unit: percent per 1000 patients

Measure	Comparison group n = 29	Training group n = 15
pre-training period	13.8 (9.2)	16.9 (9.0)
post-training period	14.1 (11.1)	11.4 (6.7)

Comparison group vs Training group: p = .05, generalized estimating equation (GEE)

Primary outcome: Use of Dermatology E-consults

Measure	Comparison group n = 29	Training group n = 15
pre-training period	5.1 (7.8)	5.5 (7.8)
post-training period	7.2 (9.2)	7.8 (7.5)

Comparison group vs Training group: p = .05, generalized estimating equation (GEE)

Adverse events

Time frame: Adverse event data from exposure to the training module was collected over 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comparison group	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Training group	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): The initial plan to randomize pods of clinicians within each of the two clinics proved not to be feasible and participation in the training module was much lower than expected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan is needed

Related trials for Cutaneous Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

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. This study is not recruiting at the moment.

Susan A Flocke, Ph.D. principal investigator

OHSU Knight Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Training and Education in people with Cutaneous Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.

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 4 inclusion and 1 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: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinician Knowledge in Melanoma Risk and Lesion Identification (time frame: Immediately before and after the training session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05675709.

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 8 Dec 2025.