An observational study in Cutaneous Melanoma, sponsored by AC Camargo Cancer Center. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by AC Camargo Cancer Center · Observational
This is an observational cohort study evaluating clinical and pathological outcomes in patients with high-risk stage II melanoma.
Patients are included after receiving treatment as part of routine clinical practice. Decisions about treatment, including whether to start anti-PD1 therapy before surgery, are made by the treating physician and are not influenced by the study.
The study compares outcomes between patients who started anti-PD1 therapy before surgery and those treated according to the usual timing in clinical practice.
No treatments are assigned as part of the study.
This study evaluates the association between the timing of anti-PD1 therapy initiation and clinical outcomes in patients with high-risk stage II melanoma (stages IIB and IIC) and/or microsatellitosis.
The study is designed as an ambispective observational cohort, including both retrospective and prospective patients treated in routine clinical practice.
The retrospective cohort includes patients who were managed according to standard clinical practice, typically undergoing surgical treatment followed by systemic/adjuvant anti-PD1 therapy. The prospective cohort includes patients who initiated anti-PD1 therapy prior to surgery, based on the treating physician's clinical judgment.
All treatment decisions, including the timing of systemic therapy initiation, are made independently by the treating physician and are not influenced by the study protocol. No interventions are assigned as part of the study, and no experimental treatment strategies are implemented.
Patients are categorized according to the timing of anti-PD1 therapy initiation (before surgery or according to standard timing), and outcomes are compared descriptively between these groups.
The study aims to explore whether early initiation of systemic therapy in routine clinical practice is associated with differences in time to treatment initiation and key clinical outcomes, including recurrence-free survival, overall survival, and pathological response.
Given its observational design, the study does not aim to establish causality but rather to generate real-world evidence regarding the potential impact of early anti-PD1 therapy in this high-risk population. As a non-randomized observational study, the results may be subject to confounding factors and selection bias inherent to real-world clinical practice.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 250 is above the median of 187 across 488 observational studies indexed under Melanoma.
Browse Melanoma studies →AC Camargo Cancer Center is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
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Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Adults (≥18 years) with confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who initiated anti-PD1 therapy prior to surgery, based on routine clinical decision-making. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Other: Anti-PD1 Therapy Timing
Patients who underwent surgery followed by systemic/adjuvant anti-PD1 therapy according to standard clinical practice. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Other: Anti-PD1 Therapy Timing
This is an observational study variable. The timing of anti-PD1 therapy initiation in relation to surgery is determined by the treating physician as part of routine clinical practice. The study does not assign or modify any treatment.
Time to initiation of systemic therapy
Time from date of diagnosis to the start of systemic or adjuvant therapy.
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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AC Camargo Cancer Center