Evidence map›Paper›PMID 39513962›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

A Tumor-Naïve ctDNA Assay Detects Minimal Residual Disease in Resected Stage II or III Colorectal Cancer and Predicts Recurrence: Subset Analysis from the GALAXY Study in CIRCULATE-Japan.

Yoshiaki Nakamura, Kristiyana Kaneva, Christine Lo, Daniel Neems, Jonathan E Freaney, Hala Boulos, Seung Won Hyun, Farahnaz Islam, Jason Yamada-Hanff, Terri M Driessen and 18 more

Abstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Article
  2. Circulating Tumor DNA Dynamics in Patients with Liver-Limited Metastatic Colorectal Cancer Resected after First-Line Systemic Treatment.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  3. Observational
  4. Article
  5. Novel Liquid Biopsy in Gastrointestinal Cancers.Journal of gastroenterology and hepatology · 2026
    Review
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  12. Observational
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  15. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Yoshiaki NakamuraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-5241-6855
Kristiyana KanevaTempus AI, Inc., Chicago, Illinois.ORCID 0000-0002-4538-5106
Christine LoTempus AI, Inc., Chicago, Illinois.ORCID 0000-0003-0969-9973
Daniel NeemsTempus AI, Inc., Chicago, Illinois.ORCID 0009-0004-7623-891X
Jonathan E FreaneyTempus AI, Inc., Chicago, Illinois.ORCID 0009-0003-4738-4267
Hala BoulosTempus AI, Inc., Chicago, Illinois.ORCID 0009-0007-8585-4265
Seung Won HyunTempus AI, Inc., Chicago, Illinois.ORCID 0009-0006-4505-3423
Farahnaz IslamTempus AI, Inc., Chicago, Illinois.ORCID 0000-0002-8331-9871
Jason Yamada-HanffTempus AI, Inc., Chicago, Illinois.ORCID 0000-0002-9331-2921
Terri M DriessenTempus AI, Inc., Chicago, Illinois.ORCID 0000-0002-9116-5497
Anne SonnenscheinTempus AI, Inc., Chicago, Illinois.ORCID 0009-0000-9836-6200
Dana F DeSantisTempus AI, Inc., Chicago, Illinois.ORCID 0000-0001-5875-4962
Daisuke KotaniDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-4196-555X
Jun WatanabeDepartment of Colorectal Surgery, Kansai Medical University, Hirakata, Japan.ORCID 0000-0002-7187-3664
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.ORCID 0000-0001-5976-613X
Saori MishimaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-5922-1487
Hideaki BandoDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5041-2765
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.ORCID 0000-0001-6269-9345
Hiroya TaniguchiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0003-1407-6682
Ichiro TakemasaDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Japan.ORCID 0000-0003-1595-2453
Takeshi KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID 0000-0001-5347-550X
Chithra SangliTempus AI, Inc., Chicago, Illinois.ORCID 0009-0000-1234-7122
Robert TellTempus AI, Inc., Chicago, Illinois.ORCID 0009-0002-0482-3701
Richard BlidnerTempus AI, Inc., Chicago, Illinois.ORCID 0009-0008-2482-8351
Takayuki YoshinoDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-0489-4756
Kate SasserTempus AI, Inc., Chicago, Illinois.ORCID 0009-0009-2804-1684
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-9763-9366
Halla NimeiriTempus AI, Inc., Chicago, Illinois.ORCID 0000-0002-8760-6456

Funding

Tempus AI, Inc.
6 · The paper itself

Abstract

purposeAnalysis of ctDNA may enable early identification of patients likely to relapse, presenting an opportunity for early interventions and improved outcomes. Tumor-naïve plasma-only approaches for minimal residual disease (MRD) assessment accelerate turnaround time, enabling rapid treatment decisions and ongoing surveillance. EXPERIMENTAL

designPlasma samples were obtained from 80 study participants with stage II or III colorectal cancer selected from CIRCULATE-Japan GALAXY. MRD status was assessed using a tumor-naïve ctDNA assay (xM) that integrates methylation and genomic variant data, delivering a binary call. MRD was assessed at 4 weeks postsurgery [landmark time point (LMT)] using methylation and genomic variant data and longitudinally (median, 22.1 months) using only methylation data.

resultsAt LMT, 69/80 study participants were evaluable (36 recurrent; 33 nonrecurrent). Of recurrent study participants, 22/36 had detectable ctDNA (MRD-positive) at LMT and 29/33 nonrecurrent study participants had undetectable ctDNA (MRD-negative), yielding a clinical sensitivity of 61.1% and specificity of 87.9%. Additionally, 74 study participants were evaluable for longitudinal performance with a clinical sensitivity of 83.3% and specificity of 89.5%. The median lead time from the first MRD-positive result to recurrence was 4.77 months overall, and 5.30 months for study participants with no adjuvant treatment. At 12 weeks postsurgery, MRD status strongly correlated with disease-free survival (adjusted HR, 9.69), outperforming carcinoembryonic antigen correlation (HR, 2.13).

conclusionsThis tumor-naïve MRD assay demonstrated clinically meaningful performance at LMT and longitudinally, accurately predicting clinical recurrence. MRD status was a stronger prognostic biomarker for disease-free survival compared with standard-of-care carcinoembryonic antigen.

Indexed as

Biomarkers, TumorCirculating Tumor DNAColorectal NeoplasmsNeoplasm Recurrence, LocalNeoplasm, ResidualAdultAgedAged, 80 and overDNA MethylationFemaleHumansJapanMaleMiddle AgedNeoplasm StagingPrognosisBiomarkers, TumorCirculating Tumor DNA

Identifiers

PMID39513962
PMCPMC11739780

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.