Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The participants eligible for this epidemiological study are those with completely resected Stage II (high risk)/III CRC (per the American Joint Committee on Cancer (AJCC) 8th revised edition staging system) due to receive standard of care chemotherapy for at least 3 months following surgery.

Blood samples for in vitro testing of ctDNA status will be drawn at study visits every three months

Regular blood sample collection for ctDNA assessment

BioNTech clinical trials patient information

BioNTech Responsible Person

This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of 630 days thereafter, according to CRC stages and disease characteristics.

Participants receive no therapeutic intervention as part of this study. This study will identify participants who might be potential candidates for the clinical trial BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard AdCTx in this patient population. Based on the eligibility criteria for that trial, this study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection and are therefore at high risk of disease recurrence to enrich the BNT122-01 study cohort. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that trial if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from BNT000-001 will be carried across to the BNT122-01 trial where feasible.

* Blood and tumor tissue samples collected for ctDNA assessment will be destroyed when subsequent clinical validity and/or bridging studies to support the validation of ctDNA assay are completed (where the samples are not exhausted).
* Remaining biospecimens from a particular participant must be destroyed if the participant specifically requests that their archival specimens are destroyed upon their withdrawal from the study.
* Remaining archival tissue blocks will be returned to the site upon request or no later than the time of final closure of the study database, whichever occurs first. For participants who are not eligible for enrollment in study BNT122-01, remaining archival tissue blocks will be returned to the site no later than 6 months after eligibility determination.

Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

Epidemiological Study to Determine the Prevalence of ctDNA Positivity in Participants With Stage II (High Risk) or Stage III CRC After Surgery With Curative (R0) Intent and Subsequent Adjuvant Chemotherapy With Monitoring of ctDNA During Clinical Follow-up

Blood sample taken post-surgery and pre-adjuvant chemotherapy.

Blood sample taken post-adjuvant chemotherapy.

The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.

Spots Global Cancer Trial Database for regular blood sample collection for ctdna assessment