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WithdrawnNCT04045236FUCOREUpdated Mar 23, 2023

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

An observational study in Non Metastatic Rectal Cancer, sponsored by Niguarda Hospital. Withdrawn at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Niguarda Hospital · Observational

Why this study was withdrawn
no pts enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Non Metastatic Rectal Cancer

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03

In context

Rectal Neoplasms

1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

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Lead sponsor

Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • non metastatic rectal cancer with the indication for a curative treatment

Exclusion criteria

Exclusion Criteria:

  • N/A
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Non metastatic rectal cancer

    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.

    Other: Registry

Interventions

  • OtherRegistry

    Data collection

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What researchers measure

Primary outcomes

  1. Disease free survival

    Survival rate

    Time frame: at 5 years from surgery

  2. Over all survival

    Survival rate

    Time frame: at 5 years from surgery

  3. Local recurrences

    Recurrences rate

    Time frame: at 5 years from surgery

  4. Distant recurrence

    Recurrences rate

    Time frame: at 5 years from surgery

Secondary outcomes

  1. Quality of life Scale (QOLS)

    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.

    Time frame: at 5 years from surgery

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Study locations

1 site
  • ASST Grande Ospedale Metropolitano Niguarda
    Milano, Italia 20162, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04045236
Lead sponsor
Niguarda Hospital
Responsible party
Sponsor
First posted
Aug 5, 2019
Start date
Oct 1, 2021
Primary completion
Dec 1, 2021
Completion
Sep 1, 2022
Last update
Mar 23, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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