Evidence map›Paper›PMID 23660123›Full record

ArticleLancet (London, England)2013

Safety and tolerability of an intratumorally injected DNAzyme, Dz13, in patients with nodular basal-cell carcinoma: a phase 1 first-in-human trial (DISCOVER).

Eun-Ae Cho, Fergal J Moloney, Hong Cai, Annie Au-Yeung, Carlos China, Richard A Scolyer, Benafsha Yosufi, Mark J Raftery, Jason Z Deng, Stephen W Morton and 8 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Lancet (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% 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, 1 synthesis or guideline pooled it, 105 citations in OpenAlex.

  1. Interventions for basal cell carcinoma of the skin.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Jun, an Oncological Foe or Friend?International journal of molecular sciences · 2025
    Review
  10. Single-stranded DNA oligonucleotides containing CpG motifs are non-stimulatoryFrontiers in cellular and infection microbiology · 2024
    Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Solution NMR Spectroscopy as a Tool to Study DNAzyme Structure and Function.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 4 countries.

Eun-Ae ChoDermatology, Sydney Medical School, Bosch Institute, Royal Prince Alfred Hospital at University of Sydney, Sydney, NSW, Australia.
Fergal J Moloney
Hong Cai
Annie Au-Yeung
Carlos China
Richard A Scolyer
Benafsha Yosufi
Mark J Raftery
Jason Z Deng
Stephen W Morton
Paula T Hammond
Hendrik-Tobias Arkenau
Diona L Damian
Douglas J Francis
Colin N Chesterman
Ross St C Barnetson
Gary M Halliday
Levon M Khachigian
UNSW Sydney · AURoyal Prince Alfred Hospital · AUMassachusetts Institute of Technology · USMelanoma Institute Australia · AUSarah Cannon Research Institute · GBServices Australia · AUUniversity of Sydney · AUWoolcock Institute of Medical Research · AU

Funding

VIRUS PRODUCTION COREP30CA014051 · NCI · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI MATTHEW G. VANDER HEIDEN · 1985 to 2026
$93.9M
NCI NIH HHS P30 CA014051
6 · The paper itself

Abstract

backgroundThe nuclear transcription factor c-Jun is preferentially expressed in basal-cell carcinoma. Dz13 is a deoxyribozyme that targets JUN messenger RNA and has inhibited the growth of a range of tumours in mice. We did a phase 1 study to assess safety and tolerability in human beings.

methodsAdults with nodular basal-cell carcinoma were recruited from Royal Prince Alfred Hospital, Sydney, Australia, between September, 2010, and October, 2011. Patients were assigned to receive one intratumoral injected dose of 10, 30, or 100 μg Dz13, in a 50 μL volume of lipid carrier, and were assessed for adverse effects in the first 24 h then at 7, 14, and 28 days after injection. Treated tumours were surgically excised 14 days after injection and compared with the baseline biopsy samples for expression of c-Jun and tumorigenesis markers.

findingsNine patients were recruited, of whom three received each dose of Dz13. All patients completed the study with no drug-related serious adverse events. No systemic Dz13 exposure was detected. c-Jun expression was reduced in the excised tumours of all nine (100%) patients, compared with baseline, and histological tumour depth had decreased in five (56%) of nine. Proportions of cells positive for caspases 3, 8, and 9 and P53 were increased, but those of cells positive for Bcl-2 and MMP-9 were decreased. Infiltration by inflammatory and immune cells was stimulated.

interpretationDz13 was safe and well tolerated after single intratumoral injections at all doses.

fundingCancer Institute NSW, Cancer Council Australia, and National Health and Medical Research Council.

Indexed as

Antineoplastic AgentsBasal Cell CarcinomaDNA, CatalyticFemaleHumansInjections, IntralesionalMaleMaximum Tolerated DoseMiddle AgedSkin NeoplasmsTreatment OutcomeAntineoplastic AgentsDNA, CatalyticDz13 DNAzyme

Identifiers

PMID23660123
PMCPMC3951714
OpenAlexW2107303903

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.