Evidence map›Paper›PMID 36796877›Full record

ReviewJournal for immunotherapy of cancer2023

Regulatory implications of ctDNA in immuno-oncology for solid tumors.

Paz J Vellanki, Soma Ghosh, Anand Pathak, Michael J Fusco, Erik W Bloomquist, Shenghui Tang, Harpreet Singh, Reena Philip, Richard Pazdur, Julia A Beaver

2 registry-linked trialsOpen access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
13.4field-weighted citation impact, top 1% 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.

NCT06207032 recruitingnot on this mapstarted 2024, after this paper: background citation

TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

TypeobservationalSponsorTempus AIRan2024 to 2029Enrolled500ConditionsCancer
NCT07154823 recruitingnot on this mapstarted 2026, after this paper: background citation

A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies

Typeobservational_patient_registrySponsorTempus AIRan2026 to 2035Enrolled550ConditionsAcute Myeloid Leukaemia (AML), Follicular Lymphoma ( FL)ArmsNone - Observational Study
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

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  12. Practical integration of ctDNA-defined minimal residual disease in gastrointestinal cancers: testing windows and evidence-aligned management frameworks.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    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

10 authors at 3 institutions in 1 country.

Paz J VellankiCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA Paz.Vellanki@fda.hhs.gov.
Soma GhoshCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA.
Anand PathakCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA.
Michael J FuscoCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Erik W BloomquistCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Shenghui TangCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Harpreet SinghCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Reena PhilipOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
Richard PazdurOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
Julia A BeaverOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
United States Food and Drug Administration · USCenter for Drug Evaluation and Research · USCenter for Devices and Radiological Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the era of precision oncology, use of circulating tumor DNA (ctDNA) is emerging as a minimally invasive approach for the diagnosis and management of patients with cancer and as an enrichment tool in clinical trials. In recent years, the US Food and Drug Administration has approved multiple ctDNA-based companion diagnostic assays for the safe and effective use of targeted therapies and ctDNA-based assays are also being developed for use with immuno-oncology-based therapies. For early-stage solid tumor cancers, ctDNA may be particularly important to detect molecular residual disease (MRD) to support early implementation of adjuvant or escalated therapy to prevent development of metastatic disease. Clinical trials are also increasingly using ctDNA MRD for patient selection and stratification, with an ultimate goal of improving trial efficiency through use of an enriched patient population. Standardization and harmonization of ctDNA assays and methodologies, along with further clinical validation of ctDNA as a prognostic and predictive biomarker, are necessary before ctDNA may be considered as an efficacy-response biomarker to support regulatory decision making.

Indexed as

Circulating Tumor DNAPrecision MedicineHumansMedical OncologyNeoplasm, ResidualPrognosisUnited StatesCirculating Tumor DNAClinical Trials as TopicImmunotherapyReview

Identifiers

PMID36796877
PMCPMC9936292
OpenAlexW4321116126

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.