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NCT06562348: ctDNA-RECIST
The ctDNA-RECIST Trial Part One
Phase 2 trial testing Standard of care in Gastrointestinal Neoplasm in 167 participants. Currently enrolling.
1 September 2029
Quick facts
| Lead sponsor | Karen-Lise Garm Spindler |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 167 |
| Start date | 15 January 2025 |
| Primary completion | 1 September 2029 |
| Estimated completion | 1 September 2030 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Standard of care
- ctDNA-RECIST guided palliative systemic treatment
Conditions studied
- Gastrointestinal Neoplasm — all drugs for Gastrointestinal Neoplasm →
Sponsor
Karen-Lise Garm Spindler — full company profile →
Who can join
18 and older, any sex, with Gastrointestinal Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Prognostic Impact of Early ctDNA Kinetics in Metastatic Pancreatic Cancer Using the ctDNA-RECIST.
Steiniche MM, Lindgaard SC, Chen IM, Johansen JS, et al · · 2025 · cited 3× · PMID 40970773 · DOI 10.1158/1078-0432.ccr-25-0758 -
Systematic review and meta-analysis of studies assessing circulating tumor DNA kinetics in metastatic colorectal cancer.
Callesen LB, Spindler KG. · · 2026 · PMID 41809060 · DOI 10.1016/j.esmogo.2026.100314
Verify or expand the search:
- PubMed search for NCT06562348
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Gastrointestinal Neoplasm
Currently open trials in the same condition.
- NCT06134687 — Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection · NA · recruiting
- NCT06159634 — Traction vs. No Traction in Colonic ESD · NA · recruiting
Other Karen-Lise Garm Spindler trials
Trials by the same sponsor.
- NCT04680260 — OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer · Phase 2 · recruiting
- NCT05385250 — Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II · NA · active not recruiting
- NCT03748680 — IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postop · Phase 2 · unknown
- NCT03750175 — OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06562348 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karen-Lise Garm Spindler
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06562348.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing