Last reviewed · How we verify
NCT06299878: CRISTINA
MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]
trial testing Gut microbiota analysis in Melanoma, Skin in 72 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Russian Academy of Medical Sciences |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 72 |
| Start date | 1 January 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Gut microbiota analysis
Conditions studied
- Melanoma, Skin — all drugs for Melanoma, Skin →
- Melanoma Stage Iii — all drugs for Melanoma Stage Iii →
Sponsor
Russian Academy of Medical Sciences — full company profile →
Who can join
18 and older, any sex, with Melanoma, Skin or Melanoma Stage Iii. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are: * radiological and pathological response rate to three doses of antiPD1 agents; * do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery. After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06299878
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melanoma, Skin
Currently open trials in the same condition.
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- NCT06809491 — One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy · active not recruiting
- NCT06666790 — DermaSensor Postmarket Surveillance Study · NA · recruiting
- NCT06605417 — Understanding the Transition from Normal Melanocytes to Nevus to Melanoma · recruiting
Other Russian Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT04353050 — Atypical MOLes and Melanoma Early Detection Study (MoleMed) · NA · unknown
- NCT04308980 — Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment · Phase 2, PHASE3 · unknown
- NCT04689282 — Intranasal Inhalations of M2 Macrophage Soluble Factors in Children With Developmental Speech Disorders · Phase 1, PHASE2 · completed
- NCT04252144 — Study of Dietary Patterns and Food Diversity in Russian GERD Patients · NA · unknown
- NCT04025424 — Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06299878 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Russian Academy of Medical Sciences
- Last refreshed: 8 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06299878.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing