May 28, 2025
Comparative Efficacy of Synthetic Biology-Engineered Therapies Versus Conventional Treatments in Adult Cancer Prognosis: A Systematic Review and Meta-Analysis
- Dr. Frank Urena1
- 1St. George’s University, School of Medicine
Protocol Citation: Dr. Frank Urena 2025. Comparative Efficacy of Synthetic Biology-Engineered Therapies Versus Conventional Treatments in Adult Cancer Prognosis: A Systematic Review and Meta-Analysis. protocols.io https://dx.doi.org/10.17504/protocols.io.e6nvwqrd2vmk/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: May 28, 2025
Last Modified: May 28, 2025
Protocol Integer ID: 219038
Keywords: therapies versus conventional treatments in adult cancer prognosis, engineered therapies versus conventional treatment, comparative efficacy of synthetic biology, engineered therapy, conventional cancer treatments in adult patient, conventional cancer treatment, adult cancer prognosis, cell therapy, oncolytic virus, synthetic biology, systematic review
Abstract
This systematic review and meta-analysis aims to evaluate whether synthetic biology-engineered therapies, including CAR T-cell therapy, oncolytic viruses, and gene circuits, improve prognosis (overall survival and progression-free survival) compared to conventional cancer treatments in adult patients.
Guidelines
We will conduct comprehensive searches of PubMed, MEDLINE, Web of Science, and Scopus from January 2020 to February 2025. The search will use combinations of keywords and MeSH terms related to synthetic biology and cancer, such as “CAR T”, “chimeric antigen receptor”, “oncolytic virus”, “engineered bacteria”, “synthetic gene circuit”, “cancer therapy”, “survival”, and “clinical trial”. Filters will be applied to include only human studies involving adults. We will screen reference lists of included studies and relevant reviews. No language or geographical restrictions will be applied.
Materials
Synthetic biology therapies such as: Chimeric Antigen Receptor T-cell (CAR T-cell) therapies, TCR-engineered lymphocytes, Oncolytic viruses and engineered bacteria, Synthetic gene circuits or gene therapy platforms.
Troubleshooting
Types of study to be included
We will include randomized controlled trials (RCTs) and observational cohort studies that compare synthetic biology therapies to conventional cancer treatments in adult patients. We will exclude case reports, reviews, preclinical studies, and studies focused exclusively on pediatric populations.
Condition or domain being studied
The review focuses on adult cancer prognosis (including both hematologic and solid malignancies) and the effectiveness of synthetic biology-engineered therapies.
Participants/population
Adults (≥18 years) diagnosed with any cancer, including hematologic malignancies (e.g., lymphomas, leukemias) and solid tumors (e.g., pancreatic cancer, mesothelioma).
Comparator(s)/control
Conventional cancer treatments, including chemotherapy, radiotherapy, standard immunotherapies, targeted therapy, or surgery.
Main outcome(s)
Overall survival (OS)
Progression-free survival (PFS) / Event-free survival (EFS)
Measures of effect
Hazard ratios (HR) with 95% confidence intervals for survival outcomes. Secondary measures include response rates and quality of life indicators.
Additional outcome(s)
Objective response rates
Incidence of adverse events
Patient-reported outcomes, including quality of life
Risk of bias (quality) assessment
Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2 tool. Cohort studies will be assessed using the Newcastle-Ottawa Scale. Overall quality and strength of evidence will be judged using GRADE criteria.
Strategy for data synthesis
A narrative synthesis will summarize all eligible studies. Where applicable, meta-analysis will be conducted using random-effects models (DerSimonian-Laird method). Meta-analyses will be performed for homogeneous subsets of data (e.g., CAR T-cell therapy in lymphoma). The I² statistic will assess heterogeneity. Results will be graphically presented using forest plots. Analysis software will include RevMan and R.
Analysis of subgroups or subsets
Subgroup analyses will include: Cancer type (hematologic vs. solid), Type of synthetic therapy (CAR T-cell vs. viral vs. bacterial), Study design (RCT vs. cohort), Risk of bias (low vs. high).
Funding sources/sponsors
None declared
Conflicts of interest
None declared
Review team members and organizational affiliations
Dr. Frank Urena, Medical Student, St. George’s University
Organizational affiliation of the review
St. George’s University, School of Medicine
Type and method of review
Systematic review and meta-analysis of interventional studies
Anticipated or actual start date
March 1, 2025
Anticipated completion date
December 15, 2025
Language
English
Country
Grenada, United States