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ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 60 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants enrolled on the study will remain on study for up to 60 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether tumor DNA (genetic material) in blood can help track rectal cancer and find its return before routine scans. It is for adults with rectal cancer that has grown into or through the rectum wall or reached nearby lymph nodes, but has not spread to distant organs. The study collects blood, tissue, and health data; it does not test a treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have T3, T4, or node-positive rectal cancer: cancer has grown into or through the rectum wall or reached nearby lymph nodes, but not distant organs.
  • You have stored tumor tissue available, or you agree to have a small tissue sample taken before the study starts.
  • You can do most daily self-care and are out of bed or a chair for more than half the day (ECOG score 0–2).
  • You can receive at least 3 months of one of these chemotherapy treatments: FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX.
  • You can receive a longer course of chemotherapy with radiation, with a radiation dose of 40–54 Gy.
  • You can understand the study and agree to sign a consent form.

Who can't join

  • You have cancer in another organ when you join the study.
  • You have another serious illness that makes joining the study impractical or medically unsuitable.
  • You are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants with T3, T4, or node-positive non-metastatic rectal cancer. * Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy. * Participants must be 18 years of age or older. * ECOG 0-2. * Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX * Participants must be eligible for long course chemoradiation to 40-54 Gy. * Participants must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Participants must not have any other organ cancer evident at the time of enrollment. * Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate. * Participants must not be actively or planning to be pregnant or breastfeeding

Study sites (2)

MA