MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

RecruitingOBSERVATIONAL
Enrollment

72

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

July 1, 2025

Conditions
Melanoma, SkinMelanoma Stage Iii
Interventions
DIAGNOSTIC_TEST

Gut microbiota analysis

Patients with resectable stage IIIB-D melanoma will have a lymph node core biopsy to confirm metastatic lesions, following standard procedures. Additionally, a portion of the tumor tissue will be preserved for biomarker analysis. Participants will then be instructed to submit fecal samples and complete a dietary questionnaire before receiving three doses of PD1 monotherapy, in accordance with the center\'s routine practice, typically spanning 6-10 weeks. Between weeks 10 and 12, a radiological assessment of the response will be conducted. Following this, participants will undergo regional lymphadenectomy, and the pathological response will be evaluated. After surgery, patients will be placed on adjuvant therapy for 12 months as per routine practice of the center . Subsequently, they will be monitored for five years, adhering to the institution\'s standard follow-up protocol.

Trial Locations (1)

115478

RECRUITING

N.N. Blokhin Russian Cancer Research Center, skin tumor department, Moscow

All Listed Sponsors
lead

Russian Academy of Medical Sciences

OTHER