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NCT Number: NCT06589388

ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer

This is a prospective observational study with three primary objectives:

Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before, during, and after total neoadjuvant therapy (TNT).

Determine the detection rate and change of CtDNA in blood samples of cancer patients before, during, and after TNT then assess changes in ctDNA expression within the study population during treatment.

* Determine the ctDNA positivity rate before treatment. * Determine the ctDNA positivity rate during TNT. * Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment.

Objective 2: Investigate the relationship between ctDNA expression and MRI/CT scan imaging with the pathological complete response (pCR) to neoadjuvant therapy :

* Correlation between ctDNA detection and pCR/TRG/NAR score. Calculate the Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI/CT scan imaging and pCR. Calculate the PPV and NPV of MRI/CT scan * Combination of ctDNA detection and MRI/CT scan imaging to predict pCR. Calculate the PPV and NPV of the combined markers.

Objective 3: Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Stage II Rectal Cancer Stage III Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a prospective observational study conducted at the Medical Genetics Institute (MGI), in collaboration with 3 hospitals (175 Military Hospital, Nguyen Tri Phuong Hospital, and 108 Military Central Hospital). Participants must meet all inclusion criteria and no exclusion criteria (detailed in the eligibility section).

Sample Collection

  • 10 mL of peripheral blood (Streck tubes) is collected for ctDNA analysis at 3 time points: pre-TNT (at diagnosis), middle of treatment (after chemoradiotherapy or after chemotherapy), and post-TNT (before surgery).
  • 6-8 slides (6um thickness/slide) of FFPE biopsy tumor samples before treatment
  • 6-8 slides (6um thickness/slide) of FFPE tumor samples collected after surgery. This sample is used to compare the mutational profiles with the corresponding biopsy samples.

Clinical results for collection

  • Age, sex, medical history
  • Number, size, and stage (TNM) of tumor
  • MRI and/or CT scan images and reports at pre-treatment, mid-treatment, and end-treatment (before surgery)
  • Histopathological evaluation of biopsy and surgery tissues, and conclusion of pathological response
  • TNM classification, pCR conclusion
  • TRG conclusion
  • Disease-free survival follow-up for 2 years

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older, both genders
  • Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy
  • Biopsy FFPE sample is available at the time of diagnosis
  • Patients consented to participate in the study

Exclusion criteria

  • Stage I rectal cancer, recurrent or metastatic cancer
  • Other cancer metastasis to the rectum
  • Patients are indicated for chemoradiation therapy only
  • Have been or are being treated for cancer
  • Patients do not agree to participate in the studies.

Treatment and study plan

Primary outcomes

  1. To investigate the detection rate and change of ctDNA in blood samples of rectal cancer patients during total neoadjuvant therapy

    Time frame: 12 months

    Determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after total neoadjuvant therapy and assess changes in ctDNA expression within the study population during treatment.

    • Determine the ctDNA positivity rate before treatment.
    • Determine the ctDNA positivity rate during total neoadjuvant therapy TNT.
    • Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment.

  2. To investigate the relationship between ctDNA expression and MRI/CT scan imaging with pCR response in total neoadjuvant therapy (TNT)

    Time frame: 6 months

    • To investigate the prediction value of ctDNA to pathological complete response (pCR) in TNT: Calculate the percentage PPV, NPV of ctDNA to pCR
    • To investigate the prediction value of MRI/CT results to pCR in TNT: Calculate the percentage PPV, NPV of MRI/CT scan (RECIST 1.1) to pCR
    • To investigate the prediction value of MRI/CT results combined ctDNA results to pCR in TNT: Calculate the percentage PPV, NPV of MRI/CT combined ctDNA to pCR

  3. Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients in 2 years

    Time frame: 24 months

    Create a Kaplan-Meier curve to estimate the disease-free survival of two years according to the after-treatment ctDNA status of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Lan NL Tu, PhD

CONTACT

[email protected]

+84888843489

Van T Phan, MSc

CONTACT

[email protected]

+84908145990

Sponsors and collaborators

Lead sponsor

Gene Solutions

Industry

Registry information

Official study title

ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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