Clinical trial NCT05356585: Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Official title: Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Cancer
Rectal Cancer
Keywords: total neoadjuvant treatment
tumor-specific assay
Circulating Tumor DNA
ctDNA
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will consist of individuals of any gender who are 18 years of age or older. They will all have a diagnosis of stage II or III rectal adenocarcinoma or adenoma.

Brief summary: The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.

Detailed description: Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.

One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).

The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .

The secondary objectives of the study include:

1. Estimating the change in ctDNA after chemoradiation and chemotherapy
2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA
3. Describe the recurrence rate in participants with and without ctDNA after TNT
4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.

Eligibility criteria: Inclusion Criteria:

* Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
* Plan is for participant to undergo standard TNT with induction chemoradiation
* Age ≥ 18 years of age

Exclusion Criteria:

* Stage I, recurrent, or metastatic rectal cancer
* Received prior therapy for this rectal cancer
* No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development

Primary outcomes:
measure: Detectable ctDNA at the Completion of TNT
timeFrame: up to 24 months after TNT
Secondary outcomes:
measure: Change in ctDNA
timeFrame: up to 24 months after TNT
measure: Correlation of Complete Response TNT
timeFrame: Up to 24 months after TNT
Other outcomes:
measure: The recurrence rate (local and distant) with positive ctDNA and negative ctDNA after TNT
timeFrame: Up to 24 months after TNT
measure: The correlation of ctDNA at end of TNT with relapse-free survival
timeFrame: After 2 years of surveillance post-TNT
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Smitha Krishnamurthi, MD
role: PRINCIPAL_INVESTIGATOR
References: