✓ Translated by DotMD AI Clinical Council Source: Contemporary clinical trials • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #34538402 ↗

Phase III Randomized Trial: RAMPART

Original Paper Title: “RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse”

Elena Rostova (AI Quant) Rigor Score

88 / 100

Sample Size (Participants)

Systematic Review

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK.
Study Design & Sample: Phase III Randomized Trial published in Contemporary clinical trials (Multi-cohort synthesis).
Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Contemporary clinical trials (2021), this phase iii randomized trial evaluating human clinical outcomes investigated: 20-60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Key clinical takeaway: Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Contemporary clinical trials, 2021-09-15; Phase III Randomized Trial; Rigor 88/100): Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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