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Insurance red tape may delay skin cancer surgery, new study warns

NCT ID NCT07215988

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 70 skin cancer patients to see how long it takes to get insurance approval for off-label neoadjuvant therapy (treatment before surgery). Researchers will measure approval times, out-of-pocket costs, and whether delays lead to worse surgical outcomes. The goal is to understand how insurance hurdles affect care for people with advanced skin cancers like Merkel cell carcinoma and melanoma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could highlight ways to speed up insurance approvals for off-label skin cancer treatments, potentially improving patient outcomes.
What could go wrong
This is an observational study, not a treatment trial. It only measures delays and costs, so it won't directly test if off-label treatments work better or worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, and miscellaneous rare cutaneous cancers will be recruited from The James Comprehensive Cancer Center during the course of usual care.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \* MERKEL CELL CARCINOMA * Signed informed consent * Pathology report confirming Merkel at the time of screening * Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149) * 2 cycles will be given prior to surgery (=12 weeks). * MUCOSAL MELANOMA * Signed informed consent * Pathology report confirming mucosal melanoma at the time of screening * Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -\> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks) * BASAL CELL CARCINOMA * Signed informed consent * Pathology report confirming basal cell carcinoma with subtype at the time of screening * Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response. * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists) * RARE CUTANEOUS CANCERS * Signed informed consent * Pathology report confirming squamous cell carcinoma at the time of screening * Stage II, III, or IV resectable or (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * Planned SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK * 4 cycles will be given prior to surgery (= 12 weeks) Exclusion Criteria: * \* MERKEL CELL CARCINOMA * Metastatic disease not amenable to complete resection * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy * Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment. * MUCOSAL MELANOMA * Metastatic disease not amenable to complete resection * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment. * BASAL CELL CARCINOMA * Metastatic disease not amenable to complete resection * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this basal cell carcinoma within the past year * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment. * RARE CUTANEOUS CANCERS * Metastatic disease not amenable to complete resection * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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