MAnagement of METastatic Disease in Campania (MAMETIC)

NCT04595032 | Completed

• 1 other identifier: 33/20 oss
• Study Type: observational
• Target: 3,234
• Locations: 1 country
• Sites: 1

Brief Summary

The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance. Condition or disease: Metastatic disease Intervention/treatment: Radiation Treatment

Conditions

Metastatic Disease

Keywords

Palliative care; Metastatic disease; Radiotherapy; Cancer pain; Breakthrough Cancer Pain; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

  Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological Study)

  20 months (Interval from January 2019 to August 2020)

• Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

  Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological study)

  60 months (Interval from September 2020 to September 2025)

Secondary Outcomes (12)

• Retrospective Study: a. Incidence of metastatic disease at diagnosis

  20 months (Interval from January 2019 to August 2020)

• Retrospective Study: b. Time between first diagnosis and the onset of metastases

  20 months (Interval from January 2019 to August 2020)

• Prospective Study: Level A a. Incidence of metastatic disease at diagnosis

  60 months (Interval from September 2020 to September 2025)

• Prospective Study: Level A b. Time between first diagnosis and the onset of metastases

  60 months (Interval from September 2020 to September 2025)

• Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment

  60 months (Interval from September 2020 to September 2025)

Interventions

3DCRT, IMRT, VMAT, SBRT DEVICE

Radiation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with metastatic disease candidates for radiotherapy and resident in Campania region

You may qualify if:

• Patients aged \> 18 years resident in Campania Region;
• Patients diagnosed with metastatic disease candidates for radiotherapy
• Metastatic patients candidates for radiotherapy re-treatment
• Oligometastatic patients candidates for radiotherapy; Patients who have given their consent

You may not qualify if:

• Patients aged \< 18 years
• Patients who are unable to express consent to sensitive data and radiant treatment

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale

Napoli, Campania, Italy

Location

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MeSH Terms

Conditions

Neoplasm Metastasis; Cancer Pain

Interventions

Radiotherapy, Intensity-Modulated; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paolo Muto, MD

  National Cancer Institute of Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: October 20, 2020
• Study Start: September 11, 2020
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)