NCT04084249

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

Active, enrolled NA Last updated 9 July 2024

What this trial tests

NA trial testing ctDNA-analysis in Colorectal Cancer in 359 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2020

Primary endpoint
30 June 2028

30 June 2028

Quick facts

Lead sponsor	Claus Lindbjerg Andersen
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	359
Start date	1 January 2020
Primary completion	30 June 2028
Estimated completion	30 June 2028
Sites	10 locations across Denmark

Drugs / interventions tested

• ctDNA-analysis
• Intensified Follow-up Schedule

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• ctDNA — all drugs for ctDNA →
• Gastro-Intestinal Disorder — all drugs for Gastro-Intestinal Disorder →

Sponsor

Claus Lindbjerg Andersen

Who can join

18 and older, any sex, with Colorectal Cancer or Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper.
   Dasari A, Morris VK, Allegra CJ, Atreya C, et al · · 2020 · cited 281× · PMID 32632268 · DOI 10.1038/s41571-020-0392-0
2. Research progress of CTC, ctDNA, and EVs in cancer liquid biopsy.
   Wang X, Wang L, Lin H, Zhu Y, et al · · 2024 · cited 54× · PMID 38333685 · DOI 10.3389/fonc.2024.1303335
3. ctDNA and Adjuvant Therapy for Colorectal Cancer: Time to Re-Invent Our Treatment Paradigm.
   Naidoo M, Gibbs P, Tie J. · · 2021 · cited 52× · PMID 33477814 · DOI 10.3390/cancers13020346
4. The Promise of Circulating Tumor DNA (ctDNA) in the Management of Early-Stage Colon Cancer: A Critical Review.
   Chakrabarti S, Xie H, Urrutia R, Mahipal A. · · 2020 · cited 40× · PMID 33003583 · DOI 10.3390/cancers12102808
5. Liquid biopsy into the clinics: Current evidence and future perspectives.
   Boukovala M, Westphalen CB, Probst V. · · 2024 · cited 29× · PMID 40027149 · DOI 10.1016/j.jlb.2024.100146
6. Network approach in liquidomics landscape.
   Santini D, Botticelli A, Galvano A, Iuliani M, et al · · 2023 · cited 27× · PMID 37542343 · DOI 10.1186/s13046-023-02743-9
7. Clinical Applications of Minimal Residual Disease Assessments by Tumor-Informed and Tumor-Uninformed Circulating Tumor DNA in Colorectal Cancer.
   Gong J, Hendifar A, Gangi A, Zaghiyan K, et al · · 2021 · cited 22× · PMID 34572774 · DOI 10.3390/cancers13184547
8. Finding Waldo: The Evolving Paradigm of Circulating Tumor DNA (ctDNA)-Guided Minimal Residual Disease (MRD) Assessment in Colorectal Cancer (CRC).
   Chakrabarti S, Kasi AK, Parikh AR, Mahipal A. · · 2022 · cited 20× · PMID 35804850 · DOI 10.3390/cancers14133078