ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
NCT05629442 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2026-04-23
Summary
This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care
C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.
Conditions
- Rectal Cancer
- Non Metastatic Rectal Cancer
Interventions
- OTHER
-
ctDNA
initial research biopsy, quality of life assessments and ctDNA collection
Sponsors & Collaborators
-
C2i Genomics
collaborator INDUSTRY -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Theodore S. Hong, MD · Massachusetts General Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2028-06-30
- Completion
- 2030-06-30
Countries
- United States
Study Locations
More Related Trials
-
Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer
NCT03038217 ·Status: UNKNOWN ·Phase: PHASE3
-
Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
NCT05601505 ·Status: RECRUITING ·Phase: PHASE2
-
Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
NCT06098560 ·Status: RECRUITING
-
Watchful Waiting for Complete Responders to Therapy in Rectal Cancer
NCT05526079 ·Status: RECRUITING ·Phase: PHASE2
-
Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
NCT05635630 ·Status: RECRUITING ·Phase: NA
-
The Implication of ctDNA in the Recurrence Surveillance of Stage II and III Colorectal Cancer
NCT03416478 ·Status: UNKNOWN
-
Metabolomics to Predict Treatment Response and Toxicities in Rectal Cancer
NCT06831669 ·Status: RECRUITING
-
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
NCT05563922 ·Status: RECRUITING ·Phase: PHASE2
-
GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.
NCT05674422 ·Status: ACTIVE_NOT_RECRUITING
-
Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence
NCT06143644 ·Status: ACTIVE_NOT_RECRUITING
-
Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission
NCT05964530 ·Status: RECRUITING ·Phase: NA
-
Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
NCT03573791 ·Status: RECRUITING
-
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
NCT00682786 ·Status: COMPLETED ·Phase: PHASE2
-
ctDNA for Prediction of Relapse in Gastric Cancer
NCT02887612 ·Status: UNKNOWN
-
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
NCT04405206 ·Status: UNKNOWN
-
Observational Study on the Patients With Rectal Cancer
NCT02312284 ·Status: COMPLETED
-
A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer
NCT06746298 ·Status: NOT_YET_RECRUITING
-
MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer
NCT05609149 ·Status: COMPLETED
-
Evaluation of cfDNA as a Marker of Response in Rectal Cancer
NCT04319354 ·Status: COMPLETED ·Phase: NA
-
Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer
NCT02710812 ·Status: UNKNOWN
-
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
NCT05622357 ·Status: COMPLETED ·Phase: PHASE2
-
MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)
NCT06879899 ·Status: NOT_YET_RECRUITING
-
The Value of ctDNA on Chemotherapy Efficacy for mCRC
NCT04555369 ·Status: UNKNOWN ·Phase: NA
-
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
NCT04752930 ·Status: UNKNOWN ·Phase: NA
-
Next-generation Sequencing in Gastrointestinal Cancer
NCT03476057 ·Status: UNKNOWN