Evidence map›Paper›PMID 37586869›Full record

ArticleBMJ open2023

Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study).

Tadayoshi Hashimoto, Yuichiro Tsukada, Masaaki Ito, Keisuke Kanato, Junki Mizusawa, Haruhiko Fukuda, Shunsuke Tsukamoto, Atsuo Takashima, Yukihide Kanemitsu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04288999 (JCOG1801), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 31% 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.

NCT04288999 phase3recruitingnot on this map

JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)

TypeinterventionalSponsorNational Cancer Center Hospital EastRan2019 to 2028Enrolled110ConditionsRectal Cancer RecurrentArmsChemotherapy, Preoperative radiotherapy, Procedure
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 citations in OpenAlex.

  1. Observational
  2. Review
  3. Observational
  4. Review
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

9 authors at 3 institutions in 1 country.

Tadayoshi HashimotoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-3759-1214
Yuichiro TsukadaDepartment of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan yutsukad@east.ncc.go.jp.
Masaaki ItoDepartment of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-1101-2707
Keisuke KanatoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Junki MizusawaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Shunsuke TsukamotoDepartment of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Atsuo TakashimaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Japan, Tokyo, Japan.
Yukihide KanemitsuDepartment of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Japan Clinical Cancer Research Organization · JPNational Cancer Center Hospital East · JPTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn locally recurrent rectal cancer (LRRC), surgery is a standard treatment for resectable disease. However, short-term and long-term outcomes are unsatisfactory due to the invasive nature of surgical procedures and the high proportion of local recurrence. Consequently, the identification of reliable prognostic and predictive biomarkers to guide treatment decisions may improve outcomes. The presence of circulating tumour DNA (ctDNA) in plasma after surgery may signify the presence of minimal residual disease (MRD) in various cancers. Therefore, we have launched a multi-institutional prospective observational study of ctDNA for MRD detection in conjunction with JCOG1801, a randomised, controlled phase III trial evaluating the efficacy of preoperative chemoradiotherapy (pre-CRT) compared with up-front surgery for LRRC (jRCTs031190076, NCT04288999). METHODS AND ANALYSIS: JCOG1801A1 is the first correlative study that assesses ctDNA in LRRC patients enrolled in JCOG1801. Patients randomised to up-front surgery will provide whole blood samples at three time points (prior to surgery, after surgery and after postoperative chemotherapy); those to pre-CRT will provide at five time points (prior to pre-CRT, after pre-CRT, prior to surgery, after surgery and after postoperative chemotherapy). Cell-free DNA will be extracted from plasma and analysed by Guardant Reveal, a tumour tissue-agnostic assay that assesses both genomic alterations and methylation patterns to determine the presence or absence of ctDNA. We will compare the prognosis and treatment response of patients according to their ctDNA status after surgery and at other time points. ETHICS AND DISSEMINATION: The study protocol received approval from the Institutional Review Board of National Cancer Center Hospital East on behalf of the participating institutions in February 2023. The study is conducted in accordance with the precepts established in the Declaration of Helsinki and Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Written informed consent will be obtained from all eligible patients prior to registration.

Indexed as

Cell-Free Nucleic AcidsCirculating Tumor DNARectal NeoplasmsClinical Trials, Phase III as TopicHealth FacilitiesHumansMulticenter Studies as TopicObservational Studies as TopicPrognosisRandomized Controlled Trials as TopicCell-Free Nucleic AcidsCirculating Tumor DNACHEMOTHERAPYClinical TrialColorectal surgeryGastrointestinal tumoursRADIOTHERAPY

Identifiers

PMID37586869
PMCPMC10432635
OpenAlexW4385863332

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.