Rectal Cancer Stage T1-T2IMMUNOREACT1NCT04915326
IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment
An observational study of Rectal Cancer Stage T1-T2 and Rectal Cancer Nodal Metastasis, run by University of Padova at 1 site in Italy.
Trial summary
ABSTRACT Background The current management on rectal cancer based on TNM staging has some limitations. In early rectal cancer T stage can be not sufficient to predict the nodal status and, in locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to therapy cannot be accurately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Stage T1-T2, Rectal Cancer Nodal Metastasis
- What is being tested?
- rectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 466 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Observational
- 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
Study population: STEP A Taking into account a 15% of early rectal cancer patients with nodal metastasis and a maximum of 5 prognostic factors (including markers and clinical factors) in the model, we aim to enroll 334 patients in this part of the study. STEP B The sample size was calculated to demonstrate a non-inferiority of AUC with respect to an area of 0.80, assuming an AUC of 0.90 and a non-inferiority margin of 0.05. With a type I error of 0.05 and a type II error of 0.20, we aim to analyze 66 patients with lymph node metastasis (N+) and 66 patients without lymph node metastasis (N0). Given an expected proportion of 15% of N+ patients among early rectal cancer, we estimate to enroll a total number of 66/0.15=440 patients with early rectal cancer. However, we will perform flow cytometry, transcriptomic analysis, mRNA microarray and mutational profiling only in 132 patients (66 N+ and 66 N0) in order to test the non-inferiority of AUC.
Who may be able to join
- 1. T1 and T2 rectal carcinoma operated on will be included in the study group. 2. A minimal number of 10 retrieved lymph nodes will be required for the inclusion in case of anterior resection or Miles abdominal perineal resection 3. Full availability of clinical records and at least 1 year of follow up
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Università di Padova
Padova, 35128
Marco Scarpa, MD, PhD, #39 049 821 2055, marco.scarpa@aopd.veneto.it
About this study
Official title: IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment Nodal Status Prediction in T1-T2 Rectal Cancer
ABSTRACT Background The current management on rectal cancer based on TNM staging has some limitations. In early rectal cancer T stage can be not sufficient to predict the nodal status and, in locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to therapy cannot be accurately predicted by the simple tumor regression grade. For both cases the current guidelines recommend the complete rectal resection with a total mesorectal excision. The implications for patients' quality of life are evident even in case of sphincter sparing surgery. Moreover, in both cases the cancer sample available for the analysis can be small or inexistent.
Hypothesis The main hypothesis underlying our research is that the aggressiveness of rectal cancer is determined by the complex interactions between the malignant cells and their immune microenvironment. The second hypothesis is that relevant trace of this cross talk between tumor cells and immune microenvironment can be detected in the normal mucosa surrounding the cancer according to the concept of field cancerization.
Read more
Aims The aim of this project is to analyze the healthy rectal mucosa surrounding the cancer to identify traces of immunosurveillance mechanisms and of field cancerization and to use them to obtain a composite prognostic test to predict nodal metastasis in early rectal cancer and recurrence after complete response at neoadjuvant therapy in case of locally advanced rectal cancer.
Experimental Design This prognostic test will be constructed on the combinatory analysis of the transcriptome, immune and epithelial cells cross-talk, immune checkpoints and miRNA expression in normal rectal mucosa surrounding cancer. The aim is to predict the presence of nodal metastasis in patients with early rectal cancer. In step A, we will retrospectively analyze archival tissue samples in order to identify the most performing biomarkers; in step B, we will validate the prognostic performance of the markers identified in phase I through a prospective analysis of rectal mucosa specimen.
Expected Results The anticipated outcome of this project is to generate one or different combination of markers to optimize rectal management and to predict rectal cancer patients outcome more accurately than traditional TNM staging or tumore regression grade. We expect to obtain a prognostic test from normal tissue that accurately predicts rectal cancer behavior even in case when the tumor samples are scarce (early rectal cancer) or absent (complete response to therapy) to avoid unnecessary total rectal excision.
Impact On Cancer An immunoscore specific for rectal cancer may predict tumor progression and clinical outcome more accurately and may contribute to better design a personalized therapeutic algorithm. Moreover, nowadays patients with early rectal cancer without nodal involvement and patients with potential complete response to neoadjuvant therapy still undergo total rectal excision which is a risky procedure that impairs quality of life. The use of this new prognostic test may make possible to adopt a minimally invasive approach or even simple observation if nodal involvement or residual disease are reasonably excluded.
Read the detailed description
Background The introduction of new technologies for diagnosis and screening programs led to an increasing rate of early detection of colorectal cancer [9]. This, combined to the evolution of techniques of local excision, led to the development of new strategies to reduce treatment related morbidity, especially for early rectal cancer. In fact, transanal local excision has recently received attention as an alternative to radical surgery for early rectal cancer [10]. Nevertheless, the definition of early rectal cancer and its staging and treatment algorithm are still under debate [9]. In, fact, to minimize the recurrence rate after local excision of rectal cancer, the false-negative rate of nodal staging should be minimized [11]. MRI can be helpful to better identify candidates suitable for local excision of early stage rectal cancer. However, strict MRI criteria for oncologic safety might result in considerable false-positive cases and limit the application of local excision [11]. Therefore, different markers are warranted to overcome this critical point in early rectal cancer management. A recent Swiss study on 126 rectal biopsies analyzed with microarray aimed to investigate whether immunoprobing might help in predicting lymph node involvement in this subgroup. Their results suggested that in early rectal cancers absence of CD8+ T-cell infiltration helps in predicting patients' nodal involvement [12]. Last but not least, a recent systematic review provided data suggesting that selected patients with T1/T2N0M0 rectal cancer may undergo local excision without compromising the oncological outcome otherwise conferred by total mesorectal excision [13]. High risk patients (i.e. those with low CD8 infiltrate) might benefit of chemoradiation. In fact, while guideline-concordant adoption of local excision for treatment of low-risk stage I rectal cancer is increasing, its use is also increasing for higher-risk rectal cancers that do not meet guideline criteria.
Treatment with local alone is associated with poorer long-term OS and additional studies are warranted to understand risk factor of poor outcome after local excision [14].
Hypothesis The clinical question is how to predict the presence of nodal metastasis in patients with early rectal cancer. These patients may potentially benefit of a minimally invasive treatment, a trans anal resection, provided that the nodal status can be considered negative for metastasis.
Study design Tissue samples will be obtained from cancer tissue (if possible) and from normal rectal mucosa adjacent to the cancer at surgery. The very large number of patients need to answer the two questions imply a multicentric design. Complete medical record and follow-up will be collected from each center. The analysis will be centralized mostly in Azienda Ospedaliera di Padova. The study will be articulated in two parts each of them aiming to answer to one of the above described questions. Each part of the study will be articulated in a retrospective and exploratory step (A) and in a prospective validation step (B).
- Being tested
- rectal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal resectionProcedure or surgery
every patients will undergo to the appropriate rectal resection
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | T1 and T2 rectal carcinoma operated on will be included in the study group. The first step will be a retrospective and exploratory analysis of FFPE slides retrieved from the pathology archives testing a panel of molecular marker exploring the immune reaction to the cancer (i.e. antigen presenting cells and T lymphocytes activation). Receives: Procedure: rectal resection | |
| Prospective | T1 and T2 rectal carcinoma operated on will be included in the study group. The second step will be a prospective and validating analysis. Tissue samples will be obtained from normal rectal mucosa adjacent to the cancer at the time of the trans anal or trans abdominal resection. In patients with early rectal cancer, the combination of immunological markers on healthy rectal mucosa adjacent to the cancer obtained in the part 1a of the study will be validated to identify the patients that will have not any nodal metastasis. Receives: Procedure: rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal metastasis in early rectalò cancer
Predictors of nodal matastasis of early rectal cancer
Measured: The presence of nodal metastasis will be detected at histological examination of the surgical specimen or at MRI follow up in case of minimally invasive transamnal resection at 1 year from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer Stage T1-T2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Istituto Oncologico Veneto IRCCS, Azienda ULSS 3 Serenissima, Azienda Ulss 2 Marca Trevigiana
- Responsible party
- Sponsor
- Investigators
- Marco Scarpa, MD, PhD, Principal investigator, Clinica Chirurgica I, Azienda Ospedale Università di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915326
- Sponsor's protocol ID
- AIRC IG2019 23381
- Acronym
- IMMUNOREACT1
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Simoni O, Scarpa M, Cavallin F, Kotsafti A, Marchegiani F, Stepanyan A, Tussardi G, Rosato A, Spolverato G, Angriman I, Urso EDL, Ruffolo C, Saadeh LM, Maretto I, Bao QR, Negro S, Vignotto C, Facci L, Rivella G, D'Angelo A, Matteazzi A, Galuppini F, Guzzardo V, Salmaso R, Pellegrini V, Brignola S, Ceccon C, Stecca T, Pozza A, Massani M, Pilati P, Gruppo M, Franzato B, Cataldo I, Portale G, Cipollari C, Zuin M, Laurino L, Dal Santo L, Pirozzolo G, Recordare A, Ceccarini L, Antoniutti M, Marinelli L, Brolese A, Barbareschi M, Bertalot G, Ortenzi M, Guerrieri M, Zizzo M, Dell'Atti L, Guerriero S, Piccioli A, Pozza G, Godina M, Mondi I, Verdi D, Da Lio C, Noaro G, Cola R, Bordignon G, Merenda R, Becherucci G, Gavagna L, Candioli S, Tagliente G, Tedeschi U, Parini D, Salmaso B, Businello G, Di Cristoforo L, Bergamo F, Porzionato A, Scognamiglio F, Bardini R, Pucciarelli S, Agostini M, Chiminazzo V, Gregori D, Di Camillo B, Castagliuolo I, Dei Tos AP, Fassan M, Scarpa M. IMMUNOREACT 4: Peritumoral Microenvironment Associated with Anastomotic Leaks After Surgery for Rectal Cancer. Cancers (Basel). 2026 Feb 9;18(4):571. doi: 10.3390/cancers18040571.
PubMed 41749825Becherucci G, Ruffolo C, Scarpa M, Scognamiglio F, Stepanyan A, Maretto I, Kotsafti A, De Simoni O, Pilati P, Franzato B, Scapinello A, Bergamo F, Massani M, Stecca T, Pozza A, Cataldo I, Brignola S, Pellegrini V, Fassan M, Guzzardo V, Dal Santo L, Salmaso R, Carlotta C, Dei Tos AP, Angriman I, Spolverato G, Chiminazzo V, Negro S, Vignotto C, Marchegiani F, Facci L, Rivella G, Bao QR, Baldo A, Pucciarelli S, Zizzo M, Businello G, Salmaso B, Parini D, Pirozzolo G, Recordare A, Tagliente G, Bordignon G, Merenda R, Licia L, Pozza G, Godina M, Mondi I, Verdi D, Da Lio C, Guerriero S, Piccioli A, Portale G, Zuin M, Cipollari C, Noaro G, Cola R, Candioli S, Gavagna L, Ricagna F, Ortenzi M, Guerrieri M, Tomassi M, Tedeschi U, Marinelli L, Barbareschi M, Bertalot G, Brolese A, Ceccarini L, Antoniutti M, Porzionato A, Agostini M, Cavallin F, Tussardi G, Di Camillo B, Bardini R, Castagliuolo I, Scarpa M. IMMUNOREACT 8: Immune markers of local tumor spread in patients undergoing transanal excision for clinically N0 rectal cancer. Surgery. 2025 Feb;178:108902. doi: 10.1016/j.surg.2024.09.043. Epub 2024 Nov 20.
PubMed 39572264Simoni O, Scarpa M, Castagliuolo I, Stepanyan A, Angriman I, Kotsafti A, Nacci C, Scognamiglio F, Negro S, D'Angelo A, Chiminazzo V, Businello G, Ruffolo C, Salmaso R, Franzato B, Gruppo M, Pilati P, Scapinello A, Pozza A, Stecca T, Massani M, Cataldo I, Brignola S, Dei Tos AP, Ceccon C, Guzzardo V, Vignotto C, Facci L, Maretto I, Agostini M, Marchegiani F, Becherucci G, Zizzo M, Bordignon G, Merenda R, Pirozzolo G, Recordare A, Pozza G, Godina M, Mondi I, Verdi D, Lio CD, Laurino L, Saadeh L, Rivella G, Guerriero S, Romiti C, Portale G, Cipollari C, Spolverato YC, Noaro G, Cola R, Candioli S, Gavagna L, Ricagna F, Ortenzi M, Guerrieri M, Tagliente G, Tomassi M, Tedeschi U, Salmaso B, Buzzi G, Parini D, Prando D, Zuin M, Bergamo F, Zagonel V, Porzionato A, Cavallin F, Camillo BD, Cristoforo LD, Bao QR, Pucciarelli S, Bardini R, Spolverato G, Fassan M, Scarpa M; IMMUNOREACT Study Group. IMMUNOREACT 7: Regular aspirin use is associated with immune surveillance activation in colorectal cancer. Cancer. 2024 Jul 1;130(13):2272-2286. doi: 10.1002/cncr.35297. Epub 2024 Apr 22.
PubMed 38644692Spolverato G, Fassan M, Scarpa M, Stepanyan A, De Simoni O, Scognamiglio F, Chiminazzo V, De Nardi C, Tamponi G, Negro S, Angriman I, Kotsafti A, Ruffolo C, Vignotto C, Zizzo M, Marchegiani F, Facci L, Bergamo F, Brignola S, Businello G, Guzzardo V, Dal Santo L, Salmaso R, Ceccon C, Massani M, Pozza A, Cataldo I, Stecca T, Dei Tos AP, Zagonel V, Pilati P, Franzato B, Scapinello A, Pirozzolo G, Recordare A, Merenda R, Bordignon G, Laurino L, Guerriero S, Romiti C, Portale G, Cipollari C, Candioli S, Gavagna L, Pozza G, Godina M, Mondi I, Noaro G, Ortenzi M, Guerrieri M, Tagliente G, Tomassi M, Tedeschi U, Porzionato A, Agostini M, Maretto I, Bao QR, Cavallin F, Di Camillo B, Bardini R, Castagliuolo I, Pucciarelli S, Scarpa M; IMMUNOREACT Study Group. IMMUNOREACT 6: weak immune surveillance characterizes early-onset rectal cancer. Br J Surg. 2023 Oct 10;110(11):1490-1501. doi: 10.1093/bjs/znad219.
PubMed 37478362Spolverato G, Fassan M, Capelli G, Scarpa M, Negro S, Chiminazzo V, Kotsafti A, Angriman I, Campi M, De Simoni O, Ruffolo C, Stepanyan A, Vignotto C, Scognamiglio F, Becherucci G, Rivella G, Marchegiani F, Facci L, Bergamo F, Brignola S, Businello G, Guzzardo V, Dal Santo L, Salmaso R, Massani M, Pozza A, Cataldo I, Stecca T, Dei Tos AP, Zagonel V, Pilati P, Franzato B, Scapinello A, Pirozzolo G, Recordare A, Merenda R, Bordignon G, Guerriero S, Romiti C, Portale G, Cipollari C, Zizzo M, Porzionato A, Agostini M, Cavallin F, Di Camillo B, Bardini R, Maretto I, Castagliuolo I, Pucciarelli S, Scarpa M. IMMUNOREACT 5: female patients with rectal cancer have better immune editing mechanisms than male patients - a cohort study. Int J Surg. 2023 Mar 1;109(3):323-332. doi: 10.1097/JS9.0000000000000214.
PubMed 37093072
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment Nodal Status Prediction in T1-T2 Rectal Cancer
- ClinicalTrials.gov ID
- NCT04915326
- Acronym / sponsor ID
- IMMUNOREACT1 / AIRC IG2019 23381
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Istituto Oncologico Veneto IRCCS, Azienda ULSS 3 Serenissima, Azienda Ulss 2 Marca Trevigiana
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jun 2021 (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.
ABSTRACT Background The current management on rectal cancer based on TNM staging has some limitations. In early rectal cancer T stage can be not sufficient to predict the nodal status and, in locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to therapy cannot be accurately predicted by the simple tumor regression grade. For both cases the current guidelines recommend the complete rectal resection with a total mesorectal excision. The implications for patients' quality of life are evident even in case of sphincter sparing surgery. Moreover, in both cases the cancer sample available for the analysis can be small or inexistent.
Hypothesis The main hypothesis underlying our research is that the aggressiveness of rectal cancer is determined by the complex interactions between the malignant cells and their immune microenvironment. The second hypothesis is that relevant trace of this cross talk between tumor cells and immune microenvironment can be detected in the normal mucosa surrounding the cancer according to the concept of field cancerization.
Aims The aim of this project is to analyze the healthy rectal mucosa surrounding the cancer to identify traces of immunosurveillance mechanisms and of field cancerization and to use them to obtain a composite prognostic test to predict nodal metastasis in early rectal cancer and recurrence after complete response at neoadjuvant therapy in case of locally advanced rectal cancer.
Experimental Design This prognostic test will be constructed on the combinatory analysis of the transcriptome, immune and epithelial cells cross-talk, immune checkpoints and miRNA expression in normal rectal mucosa surrounding cancer. The aim is to predict the presence of nodal metastasis in patients with early rectal cancer. In step A, we will retrospectively analyze archival tissue samples in order to identify the most performing biomarkers; in step B, we will validate the prognostic performance of the markers identified in phase I through a prospective analysis of rectal mucosa specimen.
Expected Results The anticipated outcome of this project is to generate one or different combination of markers to optimize rectal management and to predict rectal cancer patients outcome more accurately than traditional TNM staging or tumore regression grade. We expect to obtain a prognostic test from normal tissue that accurately predicts rectal cancer behavior even in case when the tumor samples are scarce (early rectal cancer) or absent (complete response to therapy) to avoid unnecessary total rectal excision.
Impact On Cancer An immunoscore specific for rectal cancer may predict tumor progression and clinical outcome more accurately and may contribute to better design a personalized therapeutic algorithm. Moreover, nowadays patients with early rectal cancer without nodal involvement and patients with potential complete response to neoadjuvant therapy still undergo total rectal excision which is a risky procedure that impairs quality of life. The use of this new prognostic test may make possible to adopt a minimally invasive approach or even simple observation if nodal involvement or residual disease are reasonably excluded.
Detailed description
Background The introduction of new technologies for diagnosis and screening programs led to an increasing rate of early detection of colorectal cancer [9]. This, combined to the evolution of techniques of local excision, led to the development of new strategies to reduce treatment related morbidity, especially for early rectal cancer. In fact, transanal local excision has recently received attention as an alternative to radical surgery for early rectal cancer [10]. Nevertheless, the definition of early rectal cancer and its staging and treatment algorithm are still under debate [9]. In, fact, to minimize the recurrence rate after local excision of rectal cancer, the false-negative rate of nodal staging should be minimized [11]. MRI can be helpful to better identify candidates suitable for local excision of early stage rectal cancer. However, strict MRI criteria for oncologic safety might result in considerable false-positive cases and limit the application of local excision [11]. Therefore, different markers are warranted to overcome this critical point in early rectal cancer management. A recent Swiss study on 126 rectal biopsies analyzed with microarray aimed to investigate whether immunoprobing might help in predicting lymph node involvement in this subgroup. Their results suggested that in early rectal cancers absence of CD8+ T-cell infiltration helps in predicting patients' nodal involvement [12]. Last but not least, a recent systematic review provided data suggesting that selected patients with T1/T2N0M0 rectal cancer may undergo local excision without compromising the oncological outcome otherwise conferred by total mesorectal excision [13]. High risk patients (i.e. those with low CD8 infiltrate) might benefit of chemoradiation. In fact, while guideline-concordant adoption of local excision for treatment of low-risk stage I rectal cancer is increasing, its use is also increasing for higher-risk rectal cancers that do not meet guideline criteria.
Treatment with local alone is associated with poorer long-term OS and additional studies are warranted to understand risk factor of poor outcome after local excision [14].
Hypothesis The clinical question is how to predict the presence of nodal metastasis in patients with early rectal cancer. These patients may potentially benefit of a minimally invasive treatment, a trans anal resection, provided that the nodal status can be considered negative for metastasis.
Study design Tissue samples will be obtained from cancer tissue (if possible) and from normal rectal mucosa adjacent to the cancer at surgery. The very large number of patients need to answer the two questions imply a multicentric design. Complete medical record and follow-up will be collected from each center. The analysis will be centralized mostly in Azienda Ospedaliera di Padova. The study will be articulated in two parts each of them aiming to answer to one of the above described questions. Each part of the study will be articulated in a retrospective and exploratory step (A) and in a prospective validation step (B).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Procedure: rectal resectionT1 and T2 rectal carcinoma operated on will be included in the study group. The first step will be a retrospective and exploratory analysis of FFPE slides retrieved from the pathology archives testing a panel of molecular marker exploring the immune reaction to the cancer (i.e. antigen presenting cells and T lymphocytes activation). |
| Prospective | – | Procedure: rectal resectionT1 and T2 rectal carcinoma operated on will be included in the study group. The second step will be a prospective and validating analysis. Tissue samples will be obtained from normal rectal mucosa adjacent to the cancer at the time of the trans anal or trans abdominal resection. In patients with early rectal cancer, the combination of immunological markers on healthy rectal mucosa adjacent to the cancer obtained in the part 1a of the study will be validated to identify the patients that will have not any nodal metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEP A Taking into account a 15% of early rectal cancer patients with nodal metastasis and a maximum of 5 prognostic factors (including markers and clinical factors) in the model, we aim to enroll 334 patients in this part of the study. STEP B The sample size was calculated to demonstrate a non-inferiority of AUC with respect to an area of 0.80, assuming an AUC of 0.90 and a non-inferiority margin of 0.05. With a type I error of 0.05 and a type II error of 0.20, we aim to analyze 66 patients with lymph node metastasis (N+) and 66 patients without lymph node metastasis (N0). Given an expected proportion of 15% of N+ patients among early rectal cancer, we estimate to enroll a total number of 66/0.15=440 patients with early rectal cancer. However, we will perform flow cytometry, transcriptomic analysis, mRNA microarray and mutational profiling only in 132 patients (66 N+ and 66 N0) in order to test the non-inferiority of AUC.
Key inclusion criteria (2 listed)
- 1. T1 and T2 rectal carcinoma operated on will be included in the study group. 2. A minimal number of 10 retrieved lymph nodes will be required for the inclusion in case of anterior resection or Miles abdominal perineal resection 3. Full availability of clinical records and at least 1 year of follow up
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| rectal resectionevery patients will undergo to the appropriate rectal resection | Procedure or surgery | Prospective, Retrospective |
Primary outcome
Nodal metastasis in early rectalò cancer
Time frame: The presence of nodal metastasis will be detected at histological examination of the surgical specimen or at MRI follow up in case of minimally invasive transamnal resection at 1 year from the operation
Predictors of nodal matastasis of early rectal cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 41749825De Simoni O, Scarpa M, Cavallin F, Kotsafti A, Marchegiani F, Stepanyan A, Tussardi G, Rosato A, Spolverato G, Angriman I, Urso EDL, Ruffolo C, Saadeh LM, Maretto I, Bao QR, Negro S, Vignotto C, Facci L, Rivella G, D'Angelo A, Matteazzi A, Galuppini F, Guzzardo V, Salmaso R, Pellegrini V, Brignola S, Ceccon C, Stecca T, Pozza A, Massani M, Pilati P, Gruppo M, Franzato B, Cataldo I, Portale G, Cipollari C, Zuin M, Laurino L, Dal Santo L, Pirozzolo G, Recordare A, Ceccarini L, Antoniutti M, Marinelli L, Brolese A, Barbareschi M, Bertalot G, Ortenzi M, Guerrieri M, Zizzo M, Dell'Atti L, Guerriero S, Piccioli A, Pozza G, Godina M, Mondi I, Verdi D, Da Lio C, Noaro G, Cola R, Bordignon G, Merenda R, Becherucci G, Gavagna L, Candioli S, Tagliente G, Tedeschi U, Parini D, Salmaso B, Businello G, Di Cristoforo L, Bergamo F, Porzionato A, Scognamiglio F, Bardini R, Pucciarelli S, Agostini M, Chiminazzo V, Gregori D, Di Camillo B, Castagliuolo I, Dei Tos AP, Fassan M, Scarpa M. IMMUNOREACT 4: Peritumoral Microenvironment Associated with Anastomotic Leaks After Surgery for Rectal Cancer. Cancers (Basel). 2026 Feb 9;18(4):571. doi: 10.3390/cancers18040571.
- Derived from this study: PubMed 39572264Becherucci G, Ruffolo C, Scarpa M, Scognamiglio F, Stepanyan A, Maretto I, Kotsafti A, De Simoni O, Pilati P, Franzato B, Scapinello A, Bergamo F, Massani M, Stecca T, Pozza A, Cataldo I, Brignola S, Pellegrini V, Fassan M, Guzzardo V, Dal Santo L, Salmaso R, Carlotta C, Dei Tos AP, Angriman I, Spolverato G, Chiminazzo V, Negro S, Vignotto C, Marchegiani F, Facci L, Rivella G, Bao QR, Baldo A, Pucciarelli S, Zizzo M, Businello G, Salmaso B, Parini D, Pirozzolo G, Recordare A, Tagliente G, Bordignon G, Merenda R, Licia L, Pozza G, Godina M, Mondi I, Verdi D, Da Lio C, Guerriero S, Piccioli A, Portale G, Zuin M, Cipollari C, Noaro G, Cola R, Candioli S, Gavagna L, Ricagna F, Ortenzi M, Guerrieri M, Tomassi M, Tedeschi U, Marinelli L, Barbareschi M, Bertalot G, Brolese A, Ceccarini L, Antoniutti M, Porzionato A, Agostini M, Cavallin F, Tussardi G, Di Camillo B, Bardini R, Castagliuolo I, Scarpa M. IMMUNOREACT 8: Immune markers of local tumor spread in patients undergoing transanal excision for clinically N0 rectal cancer. Surgery. 2025 Feb;178:108902. doi: 10.1016/j.surg.2024.09.043. Epub 2024 Nov 20.
- Derived from this study: PubMed 38644692Simoni O, Scarpa M, Castagliuolo I, Stepanyan A, Angriman I, Kotsafti A, Nacci C, Scognamiglio F, Negro S, D'Angelo A, Chiminazzo V, Businello G, Ruffolo C, Salmaso R, Franzato B, Gruppo M, Pilati P, Scapinello A, Pozza A, Stecca T, Massani M, Cataldo I, Brignola S, Dei Tos AP, Ceccon C, Guzzardo V, Vignotto C, Facci L, Maretto I, Agostini M, Marchegiani F, Becherucci G, Zizzo M, Bordignon G, Merenda R, Pirozzolo G, Recordare A, Pozza G, Godina M, Mondi I, Verdi D, Lio CD, Laurino L, Saadeh L, Rivella G, Guerriero S, Romiti C, Portale G, Cipollari C, Spolverato YC, Noaro G, Cola R, Candioli S, Gavagna L, Ricagna F, Ortenzi M, Guerrieri M, Tagliente G, Tomassi M, Tedeschi U, Salmaso B, Buzzi G, Parini D, Prando D, Zuin M, Bergamo F, Zagonel V, Porzionato A, Cavallin F, Camillo BD, Cristoforo LD, Bao QR, Pucciarelli S, Bardini R, Spolverato G, Fassan M, Scarpa M; IMMUNOREACT Study Group. IMMUNOREACT 7: Regular aspirin use is associated with immune surveillance activation in colorectal cancer. Cancer. 2024 Jul 1;130(13):2272-2286. doi: 10.1002/cncr.35297. Epub 2024 Apr 22.
- Derived from this study: PubMed 37478362Spolverato G, Fassan M, Scarpa M, Stepanyan A, De Simoni O, Scognamiglio F, Chiminazzo V, De Nardi C, Tamponi G, Negro S, Angriman I, Kotsafti A, Ruffolo C, Vignotto C, Zizzo M, Marchegiani F, Facci L, Bergamo F, Brignola S, Businello G, Guzzardo V, Dal Santo L, Salmaso R, Ceccon C, Massani M, Pozza A, Cataldo I, Stecca T, Dei Tos AP, Zagonel V, Pilati P, Franzato B, Scapinello A, Pirozzolo G, Recordare A, Merenda R, Bordignon G, Laurino L, Guerriero S, Romiti C, Portale G, Cipollari C, Candioli S, Gavagna L, Pozza G, Godina M, Mondi I, Noaro G, Ortenzi M, Guerrieri M, Tagliente G, Tomassi M, Tedeschi U, Porzionato A, Agostini M, Maretto I, Bao QR, Cavallin F, Di Camillo B, Bardini R, Castagliuolo I, Pucciarelli S, Scarpa M; IMMUNOREACT Study Group. IMMUNOREACT 6: weak immune surveillance characterizes early-onset rectal cancer. Br J Surg. 2023 Oct 10;110(11):1490-1501. doi: 10.1093/bjs/znad219.
- Derived from this study: PubMed 37093072Spolverato G, Fassan M, Capelli G, Scarpa M, Negro S, Chiminazzo V, Kotsafti A, Angriman I, Campi M, De Simoni O, Ruffolo C, Stepanyan A, Vignotto C, Scognamiglio F, Becherucci G, Rivella G, Marchegiani F, Facci L, Bergamo F, Brignola S, Businello G, Guzzardo V, Dal Santo L, Salmaso R, Massani M, Pozza A, Cataldo I, Stecca T, Dei Tos AP, Zagonel V, Pilati P, Franzato B, Scapinello A, Pirozzolo G, Recordare A, Merenda R, Bordignon G, Guerriero S, Romiti C, Portale G, Cipollari C, Zizzo M, Porzionato A, Agostini M, Cavallin F, Di Camillo B, Bardini R, Maretto I, Castagliuolo I, Pucciarelli S, Scarpa M. IMMUNOREACT 5: female patients with rectal cancer have better immune editing mechanisms than male patients - a cohort study. Int J Surg. 2023 Mar 1;109(3):323-332. doi: 10.1097/JS9.0000000000000214.
- Individual participant dataSharing planned: Undecided
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.
Marco Scarpa, MD, PhD principal investigator
Clinica Chirurgica I, Azienda Ospedale Università di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Stage T1-T2 and Rectal Cancer Nodal Metastasis, run by University of Padova at 1 site in Italy.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Scarpa, MD, PhD (#39 049 821 2672, marco.scarpa@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodal metastasis in early rectalò cancer (time frame: The presence of nodal metastasis will be detected at histological examination of the surgical specimen or at MRI follow up in case of minimally invasive transamnal resection at 1 year from the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915326, which also lists 5 linked publications.
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 7 Jun 2021.