Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer

NCT04670588 | Withdrawn FDA Device

• 1 other identifier: PRO00039395
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm observational study to determine the feasibility of assessing tumor response utilizing Circulating tumor DNA (ctDNA) in patients of with locally advanced rectal cancer (LARC) undergoing standard-of-care total neoadjuvant therapy (TNT) consisting of systemic chemotherapy (modified FOLFOX or modified FOLFIRINOX) followed by concurrent chemoradiation (50.4 Gy over approximately six weeks with concurrent radiosensitizing dose of capecitabine/5-fluorouracil).

Conditions

Rectal Cancer

Keywords

Locally advanced rectal cancer

Outcome Measures

Primary Outcomes (1)

• Mean serum ctDNA concentration

  This measure is the concentration of ctDNA in plasma expressed as mean tumor molecules (MTM)/ml at specific time points.

  Baseline, 8 weeks, 16 weeks, around 24 weeks before rectal surgery.

Secondary Outcomes (2)

• Response based on serum ctDNA level (change from baseline)

  Baseline, 8 weeks, 16 weeks, around 24 weeks before rectal surgery

• Response based on standard clinical assessments

  Baseline, 8 weeks, 16 weeks, around 24 weeks before rectal surgery.]

Study Arms (1)

Locally advanced rectal cancer patients

Patients with LARC undergoing TNT.

Diagnostic Test: Circulating tumor DNA(ctDNA) level measurement

Interventions

Circulating tumor DNA(ctDNA) level measurement DIAGNOSTIC_TEST

The ctDNA level will be measured using the Signatera platform developed by Natera, Inc. Signatera is a patient-specific, tumor informed custom-built ctDNA monitoring assay.

Locally advanced rectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT).

You may qualify if:

• Patients with histologically or cytologically documented rectal cancer eligible for total neoadjuvant therapy (TNT).
• Male or female subjects ≥18 years old.
• Rectal tumor biopsy is available for SignateraTM assay development for ctDNA measurement.
• Patients must be able to understand the informed consent form and provide written consent.

You may not qualify if:

• Patients without available rectal biopsy tissue for SignateraTM assay development.
• Patients with rectal cancer not eligible to receive standard-of-care TNT for any reason.
• Patients with undetectable ctDNA level in the baseline blood sample.
• Patients without trackable mutation in the rectal tumor.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.

  PMID: 31070691 RESULT

Related Links

• Manufacturer's site posting four scientific abstracts.

Biospecimen

Retention: SAMPLES WITH DNA

After obtaining informed consent, a venous blood sample and the archival tissue block from the initial diagnostic rectal tumor biopsy will be sent to the Natera laboratory for designing patient-specific ctDNA assay, which will be used to measure ctDNA levels in the peripheral venous blood samples at various time points.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sakti Chakrabarti, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: March 31, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)