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Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.

Registry

The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients

Study parameters

Patients with an histological diagnosis of rectal cancer will undergo pre-operative staging as follow:

* Chest-Abdominal TC scan with e.v. contrast.
* Complete colonoscopy
* Pelvic MRI with e.v. contrast with measurements of all the tumours aspects.
* Endorectal US examination
* Serum level of CEA and CA 19,9 and full nutritional status will be analysed
* Complete oncological and pathological medical history examination.
* Data from place of birth and places where patients lived will be collected.
* Sex and race Charlson Comorbidities Index adjusted for age will be calculated for each patient while Robinson Score will be calculated for aged over 70 patients.

Symptoms at presentation (Haemorrhagic framework ,alvo alteration, pain) will be collected. For Locally advance rectal cancer neo adjuvant chemoradiotherapy will be planned. Grey dose received and total dose of chemotherapy administrated together with eventual toxicity and reasons for non completing the therapy will be collected. Patients will be re-staged with pelvic MRI, endorectal US, colonoscopy. Radiological and endoscopic disease response to neo adjuvant treatment criteria will be noted.

Intraoperative analysed parameters will include :

* time of surgery
* blood loss
* type of analgesia
* type of technique, conversion
* level of IMA ligation
* if splenic flexure lowered down
* type of energy device used
* number and type of cartridge used for rectal stapled line
* size of circular stapler used for the anastomosis
* if loop ileostomy performed Isto-pathological examination will performed according to WHO 2010 guidelines, Quirke score and Dworak grade in patients who will undergo neo adjuvant chemo-radiation therapy will be reported. Mismatch repair proteins will be reported when analysed.

Post operative complication will be described according to Clavien Dindo complication scale. Day of discharge and eventual post discharge complication will be evaluated. Application of an ERAS protocol will be added only for at least 80% of ERAS colo-rectal items satisfied. Indication to eventual adjuvant therapy given within a multidisciplinary setting will be noted. Type of therapy, duration of the treatment and a full description of the compliance to the treatment will be described. Oncological follow up will be performed according to National Comprehensive Cancer Network guidelines. Functional follow up will be done yearly with the Low Anterior Resection Syndrome Score.

AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent

Rectal Cancer AIMS Academy Clinical Research Network Registry

QOLS CRC-specific questionnaire FACT-C score analisys. QOLS CRC Range: 7 maximum 1 minimum. 7 score represents a better value. FACT-C Range maximum 4 minimum 0. 4 score represents better value.

Niguarda Hospital

Symptoms and General Pathology

Pathologic Complete Response

This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care

- Except for the initial research biopsy, quality of life assessments and ctDNA collection

initial research biopsy, quality of life assessments and ctDNA collection

ctDNA

Theodore S. Hong, MD

Theodore Hong, MD

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.

The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care.

It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study .

Participants enrolled on the study will remain on study for up to 60 months.

biospecimen submission should include both tissue and blood samples:

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay.

European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer.

Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning.

Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being.

Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life.

Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function).

IADLs are things you do every day to independently take care of yourself and your home.

Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer.

BPI scale total score:

* worst pain score: 1-4 = mild pain
* worst pain score: 5-6 = moderate pain
* worst pain score: 7-10 = severe pain

Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer.

LARS total score:

* 0-20 = no dysfunction
* 21-29 = minor dysfunction
* 30-42 = major dysfunction

Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life.

Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life.

Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment.

Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life.

Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer.

Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent	NCT04045236	Non Metastatic ...	Registry	18 Years -	Niguarda Hospital
AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent	NCT04045236	Non Metastatic ...	Registry	18 Years -	Niguarda Hospital
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer	NCT05629442	Rectal Cancer Non Metastatic ...	ctDNA	18 Years -	Massachusetts General Hospital
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer	NCT05629442	Rectal Cancer Non Metastatic ...	ctDNA	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for non metastatic rectal cancer