Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy (ATLAS)
Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection
This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia.
It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers.
Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.
研究概览
地位
招聘中
详细说明
Single-center, prospective, observational cohort study.
120 patients with advanced (stage III unresectable or IV) solid tumors candidates for first-line immunotherapy and 30 healthy controls are enrolled (total N=150).
Patients provide saliva, stool and tongue-scraping samples plus archival FFPE tumor tissue at baseline (V0) and at 6 (V1) and 12 (V2) months; controls provide saliva and stool at V0 only.
Microbiomes are profiled by PacBio HiFi shotgun metagenomics and full-length 16S; tumor transcriptome by RNA-Seq; and saliva/stool metabolome by GC-MS in a subcohort (n=60).
Tumor response is assessed by RECIST 1.1.
Microbial, transcriptomic and metabolomic features are integrated with clinical outcomes (objective response, PFS, OS) using multivariable and machine-learning models.
研究类型
观察性的
注册 (估计的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liliana Gutiérrez, RN, MSc
- 电话号码：+573003768158
- 邮箱：lgutierrez@fctic.org
研究联系人备份
- 姓名：Andrés F Cardona, MD, MSc, PhD, MBA
- 电话号码：+573016348173
- 邮箱：acardona@fctic.org
学习地点
-
-
Bogota D.C.
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Bogotá、Bogota D.C.、哥伦比亚、110131
- 招聘中
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
-
接触：
- Liliana Gutiérrez, RN, MSc
- 电话号码：+573003768158
- 邮箱：lgutierrez@fctic.org
-
首席研究员：
- Andrés F Cardona, MD, MSc, PhD, MBA
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical, head-and-neck) candidates for first-line immunotherapy, plus healthy adult volunteers.
Single center: Fundación CTIC, Bogotá.
描述
Inclusion Criteria:
- Age 18 years or older.
- Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.
- Candidate for first-line immunotherapy per current clinical guidelines.
- Available FFPE tumor block in institutional or reference pathology archive.
- Able to provide saliva and stool samples at V0 and follow-up.
- ECOG performance status within protocol limits; life expectancy over 3 months.
- Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.
Inclusion Criteria (healthy controls)
- No prior cancer diagnosis.
- No active autoimmune disease; no inflammatory bowel disease.
- No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.
Exclusion Criteria:
- Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).
- Probiotics or prebiotics within 30 days.
- Chronic proton-pump inhibitors for more than 3 continuous months.
- Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.
- Pregnancy or lactation.
- BMI under 18.5 or over 40 kg/m².
- Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).
- Invasive dental treatment within 3 months.
- Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.
- Inability to ensure 12-month clinical follow-up.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients with advanced solid tumors
120 Colombian adults with advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer, candidates for first-line immunotherapy (standard of care).
Saliva, stool and tongue scraping collected at V0, V1 (6 mo) and V2 (12 mo); archival FFPE tumor block retrieved at V0.
|
Exposure observed: first-line immunotherapy with immune checkpoint inhibitors administered as standard of care (INVIMA-approved); no experimental intervention is assigned by the study.
Healthy controls receive no immunotherapy.
|
|
Healthy controls
30 healthy adult volunteers without prior cancer, active autoimmune disease or inflammatory bowel disease, and without antibiotics or invasive dental treatment in the prior 3 months.
Saliva and stool collected at V0 only; no longitudinal follow-up.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oral, fecal and intratumoral microbiome signatures associated with objective tumor response (RECIST 1.1) to first-line immunotherapy
大体时间：Baseline (V0) and through 12 months
|
Characterization of oral, fecal and intratumoral microbiomes and identification of taxa and diversity metrics differentiating responders (CR+PR) from non-responders (SD+PD) by RECIST 1.1.
|
Baseline (V0) and through 12 months
|
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Differences in microbiome composition and diversity between cancer patients and healthy controls
大体时间：Baseline (V0)
|
Comparison of alpha and beta diversity and differential taxonomic and functional abundance between cancer patients and healthy controls.
|
Baseline (V0)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS)
大体时间：Association of microbial diversity, key taxa, MAGs and functional pathways with progression-free survival, estimated by Kaplan-Meier and adjusted Cox models.
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Up to 36 months
|
Association of microbial diversity, key taxa, MAGs and functional pathways with progression-free survival, estimated by Kaplan-Meier and adjusted Cox models.
|
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Microbial biomarkers associated with overall survival (OS)
大体时间：Up to 36 months
|
Association of microbiome features with overall survival, estimated by Kaplan-Meier and adjusted Cox models.
|
Up to 36 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tumor transcriptomic profile and gene-expression pathways modulated by the intratumoral microbiome
大体时间：Baseline (V0)
|
RNA-Seq characterization of tumor gene-expression and identification of pathways correlated with intratumoral microbiome composition.
|
Baseline (V0)
|
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Untargeted salivary and fecal metabolomic profile (subcohort, n=60)
大体时间：Baseline through 12 months
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GC-MS untargeted metabolomics of saliva and stool in a stratified subcohort (50 patients, 10 controls) to identify metabolites associated with microbiome composition and immunotherapy response.
|
Baseline through 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrés F Cardona, MD, MSc, PhD, MBA、Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cullin N, Azevedo Antunes C, Straussman R, Stein-Thoeringer CK, Elinav E. Microbiome and cancer. Cancer Cell. 2021 Oct 11;39(10):1317-1341. doi: 10.1016/j.ccell.2021.08.006. Epub 2021 Sep 9.
- Mancini N, Peri F, Rescigno M, Zanoni I. Microbiome studies in the medical sciences and the need for closer multidisciplinary interplay. Sci Signal. 2020 Feb 4;13(617):eaba9911. doi: 10.1126/scisignal.aba9911.
- Zhernakova A, Kurilshikov A, Bonder MJ, Tigchelaar EF, Schirmer M, Vatanen T, Mujagic Z, Vila AV, Falony G, Vieira-Silva S, Wang J, Imhann F, Brandsma E, Jankipersadsing SA, Joossens M, Cenit MC, Deelen P, Swertz MA; LifeLines cohort study; Weersma RK, Feskens EJ, Netea MG, Gevers D, Jonkers D, Franke L, Aulchenko YS, Huttenhower C, Raes J, Hofker MH, Xavier RJ, Wijmenga C, Fu J. Population-based metagenomics analysis reveals markers for gut microbiome composition and diversity. Science. 2016 Apr 29;352(6285):565-9. doi: 10.1126/science.aad3369. Epub 2016 Apr 28.
- Dohlman AB, Arguijo Mendoza D, Ding S, Gao M, Dressman H, Iliev ID, Lipkin SM, Shen X. The cancer microbiome atlas: a pan-cancer comparative analysis to distinguish tissue-resident microbiota from contaminants. Cell Host Microbe. 2021 Feb 10;29(2):281-298.e5. doi: 10.1016/j.chom.2020.12.001. Epub 2021 Jan 6.
- Parida S, Sharma D. The Microbiome and Cancer: Creating Friendly Neighborhoods and Removing the Foes Within. Cancer Res. 2021 Feb 15;81(4):790-800. doi: 10.1158/0008-5472.CAN-20-2629. Epub 2020 Nov 4.
- Park EM, Chelvanambi M, Bhutiani N, Kroemer G, Zitvogel L, Wargo JA. Targeting the gut and tumor microbiota in cancer. Nat Med. 2022 Apr;28(4):690-703. doi: 10.1038/s41591-022-01779-2. Epub 2022 Apr 19.
- El Tekle G, Garrett WS. Bacteria in cancer initiation, promotion and progression. Nat Rev Cancer. 2023 Sep;23(9):600-618. doi: 10.1038/s41568-023-00594-2. Epub 2023 Jul 3.
- Parizadeh M, Arrieta MC. The global human gut microbiome: genes, lifestyles, and diet. Trends Mol Med. 2023 Oct;29(10):789-801. doi: 10.1016/j.molmed.2023.07.002. Epub 2023 Jul 27.
- Govender P, Ghai M. Population-specific differences in the human microbiome: Factors defining the diversity. Gene. 2025 Jan 15;933:148923. doi: 10.1016/j.gene.2024.148923. Epub 2024 Sep 6.
- Trakman GL, Fehily S, Basnayake C, Hamilton AL, Russell E, Wilson-O'Brien A, Kamm MA. Diet and gut microbiome in gastrointestinal disease. J Gastroenterol Hepatol. 2022 Feb;37(2):237-245. doi: 10.1111/jgh.15728. Epub 2021 Nov 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月11日
初级完成 (估计的)
2029年2月28日
研究完成 (估计的)
2029年8月30日
研究注册日期
首次提交
2026年6月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年6月30日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年7月3日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ATLAS
- CEI-232 (其他标识符：Comité de Ética de la Investigación Riesgo de Fractura S.A)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified genomic sequences (oral, fecal and intratumoral microbiome) will be deposited in public repositories (NCBI SRA / EBI ENA) with minimal metadata (tumor type, age by decade, sex).
Analysis pipelines and code will be versioned and shared via GitHub and Zenodo.
Raw data and code will be made public at study close.
IPD 共享时间框架
Available at study close (estimated 2029); retained at least 15 years per ICH-GCP archiving policy.
IPD 共享访问标准
Open access via public repositories (SRA, ENA, Zenodo) for de-identified sequence data and analysis code.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.