Protocol 1: 18 consented participants and three clinical groups

How consent, group assignment, participant IDs, and paired specimens become the study manifest

Purpose

The laboratory workflow begins with 18 consented participants distributed across three clinical groups: 8 high-risk ulcerative colitis, 5 colorectal cancer, and 5 healthy comparators. This is the biological sample size; downstream reads and technical replicates do not enlarge it.

Input	Process	Output
consent and eligibility documentation	assign de-identified participant ID; record group and covariates	controlled participant manifest
blood and colonic biopsy collection events	bind specimen IDs to the participant	tissue/plasma/serum linkage table
three laboratory technical replicates	bind replicate and batch IDs below each specimen	replicate-aware processing manifest

participant_id  group    specimen  replicate  collection_event  batch
P001            UC       plasma    1          C001              B1
P001            UC       tissue    1          C001              B1
P001            UC       serum     1          C001              E1

QC gate

Consent scope, eligibility, specimen identity, pairing, collection time, missingness, and protocol deviations must be resolved before molecular results are exposed. Public artifacts use de-identified IDs only.

NoteWhat this stage generates

This protocol generates metadata, not a biomarker: the authoritative key connecting every tube, library, ELISA well, clinical group, and final participant-level row.

Study design → · Next: blood processing →