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Effect of low-dose Interferon-alfa2a on perioperative immune suppression

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517619-65-00
Enrollment
68
Registered
2024-09-27
Start date
2023-08-28
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Brief summary

• Differences in measures of lymphocytic subpopulations (FLOW) between intervention and placebo group, seen as a higher number of CD3, 4, 8 and HLA-positive cells in the intervention group, on the day of and the day after surgery. • Differences in tumor-infiltrating lymphocytes in the resected specimen at the tumor center and invasive margin between the intervention and placebo group. This will be analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells.

Detailed description

A few of them: 1)Differences in measures of Quality of recovery (QoR-15) between intervention and placebo group, seen as a higher mean QoR in intervention group on the third and 12-16 post-operative day. 2) Differences in phenotype and clonality of tumor-infiltrating and circulating T cells between placebo and intervention group, analyzed via combined single-cell transcriptome and TCR sequencing. 3) Differences in tumor microenvironment in the resected specimen.

Interventions

Sponsors

Region Sjaelland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Differences in measures of lymphocytic subpopulations (FLOW) between intervention and placebo group, seen as a higher number of CD3, 4, 8 and HLA-positive cells in the intervention group, on the day of and the day after surgery. • Differences in tumor-infiltrating lymphocytes in the resected specimen at the tumor center and invasive margin between the intervention and placebo group. This will be analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells.

Secondary

MeasureTime frame
A few of them: 1)Differences in measures of Quality of recovery (QoR-15) between intervention and placebo group, seen as a higher mean QoR in intervention group on the third and 12-16 post-operative day. 2) Differences in phenotype and clonality of tumor-infiltrating and circulating T cells between placebo and intervention group, analyzed via combined single-cell transcriptome and TCR sequencing. 3) Differences in tumor microenvironment in the resected specimen.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026