Evidence map›Paper›PMID 31663904›Full record

Trial reportClinical and translational gastroenterology2019

Novel Circulating Tumor Cell Assay for Detection of Colorectal Adenomas and Cancer.

Wen-Sy Tsai, Jeng-Fu You, Hsin-Yuan Hung, Pao-Shiu Hsieh, Ben Hsieh, Heinz-Josef Lenz, Gregory Idos, Shai Friedland, Jennifer Yi-Jiun Pan, Hung-Jen Shao and 7 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Clinical and translational gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
2.0field-weighted citation impact, top 11% of its field
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

41 citing papers in PubMed, 62 citations in OpenAlex.

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  16. Potential value of detection of minimal residual disease in colorectal cancer following radical resection.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
    Article
  17. Liquid Biopsy in the Clinical Management of Cancers.International journal of molecular sciences · 2024
    Review
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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

17 authors at 4 institutions in 2 countries.

Wen-Sy TsaiDivision of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
Jeng-Fu YouDivision of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
Hsin-Yuan HungDivision of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
Pao-Shiu HsiehDivision of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
Ben HsiehCellMax Life Inc., Sunnyvale, California, USA.
Heinz-Josef LenzDivision of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine University of Southern California, Los Angeles, California, USA.
Gregory IdosDivision of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine University of Southern California, Los Angeles, California, USA.
Shai FriedlandDivision of Gastroenterology, Department of Medicine, Stanford University, Stanford, California.
Jennifer Yi-Jiun PanDivision of Gastroenterology, Department of Medicine, Stanford University, Stanford, California.
Hung-Jen ShaoCellMax Life Inc., Sunnyvale, California, USA.
Jen-Chia WuCellMax Life Inc., Sunnyvale, California, USA.
Jr-Ming LaiCellMax Life Inc., Sunnyvale, California, USA.
Shih-En ChangCellMax Life Inc., Sunnyvale, California, USA.
Rui MeiCellMax Life Inc., Sunnyvale, California, USA.
Drew WatsonKit Bio Inc., Los Altos, California, USA.
Manana JaveyCellMax Life Inc., Sunnyvale, California, USA.
Ashish NimgaonkarThe Johns Hopkins Hospital, Baltimore, Maryland, USA.
Chang Gung Memorial Hospital · TWStanford University · USUniversity of Southern California · USJohns Hopkins Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThere is a significant unmet need for a blood test with adequate sensitivity to detect colorectal cancer (CRC) and adenomas. We describe a novel circulating tumor cell (CTC) platform to capture colorectal epithelial cells associated with CRC and adenomas.

methodsBlood was collected from 667 Taiwanese adults from 2012 to 2018 before a colonoscopy. The study population included healthy control subjects, patients with adenomas, and those with stage I-IV CRC. CTCs were isolated from the blood using the CellMax platform. The isolated cells were enumerated, and an algorithm was used to determine the likelihood of detecting adenoma or CRC. Nominal and ordinal logistic regression demonstrated that CTC counts could identify adenomas and CRC, including CRC stage.

resultsThe CellMax test demonstrated a significant association between CTC counts and worsening disease status (Cuzick's P value < 0.0001) with respect to the adenoma-carcinoma sequence. The test showed high specificity (86%) and sensitivity across all CRC stages (95%) and adenomatous lesions (79%). The area under the curve was 0.940 and 0.868 for the detection of CRC and adenomas, respectively. DISCUSSION: The blood-based CTC platform demonstrated high sensitivity in detecting adenomas and CRC, as well as reasonable specificity in an enriched symptomatic patient population. TRANSLATIONAL IMPACT: If these results are reproduced in an average risk population, this test has the potential to prevent CRC by improving patient compliance and detecting precancerous adenomas, eventually reducing CRC mortality.

Indexed as

AdenomaAdultAgedAged, 80 and overBiological AssayColonColonoscopyColorectal NeoplasmsFemaleHealthy VolunteersHumansMaleMiddle AgedNeoplasm StagingNeoplastic Cells, CirculatingProof of Concept StudyReagent Kits, Diagnostic

Identifiers

PMID31663904
PMCPMC6884354
OpenAlexW2982330963

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.