Cancer of RectumNCT04319354
Evaluation of cfDNA as a Marker of Response in Rectal Cancer
A study testing Analysis of cfDNA in people with Cancer of Rectum, run by Hospital Pedro Hispano at 1 site in Portugal.
Trial summary
A pathological complete response (pCR) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. This group could, potentially, be spared the morbidity of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Rectum
- What is being tested?
- Analysis of cfDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Nov 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old, ECOG 0-2
- High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy and who are potentially eligible for curative surgery
- Patients who can fully understand the content of the informed consent form and sign it upon their own opinion
- Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-up
Who cannot join
- Patient has any underlying or current medical condition, which would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosus etc.).
- Patient has severe mental illness.
- Patient has any other conditions, which would interfere with the evaluation of the subject.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Hospital Pedro Hispano
Matosinhos Municipality, Porto District, 4464-513
About this study
Official title: Evaluation of cfDNA as a Marker of Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
A pathological complete response (pCR) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. This group could, potentially, be spared the morbidity of surgery.
The diversified response to neoadjuvant chemotherapy (nCRT) amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity.
Read more
Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response, in liquid biopsy, for rectal cancer. The concentration of baseline plasma cell-free DNA (cfDNA) appears significantly higher in responders compared to non-responders.
The objective of this study is to investigate the potential role of cfDNA as a marker of pCR (or partial response) to nCRT as well as a marker of outcomes (overall survival and disease-free survival).
The investigators are conducting a prospective, observational, cohort, non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT, followed by surgical excision 6-12 weeks later. Patients are assigned to groups according to their pathological response to nCRT. A total of 20 patients with complete pathological response, 50 partial response and 50 non-responders will be selected over a year and followed for another year. Participants will be observed and examined during the entire course of treatment and the follow-up period.
Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points (pre-nCRT, post-nCRT and postoperative week 1), incorporating analysis of concentration, dimension of DNA fragments, % of mutation frequency (CIN, APC, p53, MSI, KRAS, BRAF, EGFR, cKIT) and next-generation sequencing of tumour biopsy and surgical specimens.
This study will serve as the feasibility of a larger, comparative study.
- Conditions
- Cancer of Rectum
- Being tested
- Analysis of cfDNA
- Keywords
- rectal cancer, neoadjuvant therapy, cfDNA
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of cfDNADiagnostic test
Analysis of cfDNA through liquid biopsy
| Study group | Role | What they receive |
|---|---|---|
| pCR | Experimental | Not described Receives: Diagnostic Test: Analysis of cfDNA |
| Partial responders | Experimental | Not described Receives: Diagnostic Test: Analysis of cfDNA |
| Non-responders | Active comparator | Not described Receives: Diagnostic Test: Analysis of cfDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ryan tumor regression grade system (number of patients with complete/partial/no response)
Tumour pathological response, on surgical specimen, to neoadjuvant chemoradiotherapy
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Number of participants with 1 and 2-year disease free recurrence
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start18 Nov 2019
- Primary completion30 Apr 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of RectumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pedro Hispano
- Sponsor type
- University, hospital or other
- Collaborators
- Diogo Melo Pinto, MD, Hospital Pedro Hispano, Centro Hospitalar De São João, E.P.E., Isabel Prieto, PhD, Hospital La Paz, Madrid
- Responsible party
- Principal investigator, Marina Morais, Hospital Pedro Hispano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319354
- Sponsor's protocol ID
- 85/19/56C
- Status last verified
- May 2023
- First submitted
- 9 Mar 2020
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of cfDNA as a Marker of Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04319354
- Acronym / sponsor ID
- 85/19/56C
- Conditions
- Cancer of Rectum
- Keywords
- rectal cancer, neoadjuvant therapy, cfDNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Pedro HispanoUniversity, hospital or other
- Collaborators
- Diogo Melo Pinto, MD, Hospital Pedro Hispano, Centro Hospitalar De São João, E.P.E., Isabel Prieto, PhD, Hospital La Paz, Madrid
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pathological complete response (pCR) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. This group could, potentially, be spared the morbidity of surgery.
The diversified response to neoadjuvant chemotherapy (nCRT) amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity.
Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response, in liquid biopsy, for rectal cancer. The concentration of baseline plasma cell-free DNA (cfDNA) appears significantly higher in responders compared to non-responders.
The objective of this study is to investigate the potential role of cfDNA as a marker of pCR (or partial response) to nCRT as well as a marker of outcomes (overall survival and disease-free survival).
The investigators are conducting a prospective, observational, cohort, non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT, followed by surgical excision 6-12 weeks later. Patients are assigned to groups according to their pathological response to nCRT. A total of 20 patients with complete pathological response, 50 partial response and 50 non-responders will be selected over a year and followed for another year. Participants will be observed and examined during the entire course of treatment and the follow-up period.
Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points (pre-nCRT, post-nCRT and postoperative week 1), incorporating analysis of concentration, dimension of DNA fragments, % of mutation frequency (CIN, APC, p53, MSI, KRAS, BRAF, EGFR, cKIT) and next-generation sequencing of tumour biopsy and surgical specimens.
This study will serve as the feasibility of a larger, comparative study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pCR | Experimental | Diagnostic Test: Analysis of cfDNA |
| Partial responders | Experimental | Diagnostic Test: Analysis of cfDNA |
| Non-responders | Active comparator | Diagnostic Test: Analysis of cfDNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years old, ECOG 0-2
- High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy and who are potentially eligible for curative surgery
- Patients who can fully understand the content of the informed consent form and sign it upon their own opinion
- Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-up
Key exclusion criteria (3 listed)
- Patient has any underlying or current medical condition, which would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosus etc.).
- Patient has severe mental illness.
- Patient has any other conditions, which would interfere with the evaluation of the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of cfDNAAnalysis of cfDNA through liquid biopsy | Diagnostic test | Non-responders, Partial responders, pCR |
Primary outcome
Ryan tumor regression grade system (number of patients with complete/partial/no response)
Time frame: Through study completion, an average of 1 year
Tumour pathological response, on surgical specimen, to neoadjuvant chemoradiotherapy
1 secondary outcome
Number of participants with 1 and 2-year disease free recurrence
Time frame: 1 and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of cfDNA in people with Cancer of Rectum, run by Hospital Pedro Hispano at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ryan tumor regression grade system (number of patients with complete/partial/no response) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.