## Protocol Section
### Identification Module
**NCT ID:** NCT06429995

**Acronym:** SFPMAMMA

**Brief Title:** Standard Follow-up Program (SFP) for Breast Cancer Patients

**Official Title:** Standard Follow-up Program (SFP) for Breast Cancer Patients

#### Organization Study ID Info
**ID:** SFP MAMMA
#### Organization
**Class:** OTHER
**Full Name:** University Medical Center Groningen
### Status Module
#### Completion Date
**Date:** 2030-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2030-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Medical Center Groningen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.

Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- Acute toxicity

- Late toxicity

- Prediction models

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 30 Years

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Radiotherapy

**Other Names:**

- chemoradiation

**Type:** RADIATION

### Outcomes Module

#### Other Outcomes

**Description:** Hb level (mmol/l) measured in blood

**Measure:** Hemoglobin (Hb)

**Time Frame:** Before start of radiation therapy

**Description:** Ht levels (L/L) measured in blood

**Measure:** Hematocrit (Ht)

**Time Frame:** Before start of radiation therapy

**Description:** Leukocytes + differential count (10E9/l) measured in blood

**Measure:** Leukocytes

**Time Frame:** Before start of radiation therapy

**Description:** Creatinine levels (mmol/l) measured in blood

**Measure:** Creatinine

**Time Frame:** Before start of radiation therapy

**Description:** eGFR calculated from creatinine levels (ml/min)

**Measure:** Estimated Glomerular filtration rate (eGFR)

**Time Frame:** Before start of radiation therapy

**Description:** Urea levels (mmol/l) measured in blood

**Measure:** Urea

**Time Frame:** Before start of radiation therapy

**Description:** HbA1c levels (mmol/mol) measured in blood

**Measure:** Hemoglobin A1c (HbA1c)

**Time Frame:** Before start of radiation therapy

**Description:** Cholesterol levels (mmol/L) measured in blood

**Measure:** Cholesterol

**Time Frame:** Before start of radiation therapy

**Description:** HDL cholesterol levels (mmol/L) measured in blood

**Measure:** High-densitiy-lipoprotein cholesterol (HDL cholesterol)

**Time Frame:** Before start of radiation therapy

**Description:** LDL cholesterol levels (mmol/L) measured in blood

**Measure:** Low-density-lipoprotein cholesterol (LDL cholesterol)

**Time Frame:** Before start of radiation therapy

**Description:** Triglycerides levels (mmol/L) measured in blood

**Measure:** Triglycerides

**Time Frame:** Before start of radiation therapy

**Description:** HsCRP levels (mg/L) measured in blood

**Measure:** High sensitive C-reactive protein (hsCRP)

**Time Frame:** Before start of radiation therapy

**Description:** TSH levels (mU/L) measured in blood

**Measure:** Thyroid stimulating hormone (TSH)

**Time Frame:** Before start of radiation therapy, 1 and 2 years after radiation therapy

**Description:** FT4 levels (pmol/L) measured in blood

**Measure:** Free Thyroxine-4 (FT4)

**Time Frame:** Before start of radiation therapy, 1 and 2 years after radiation therapy

**Description:** Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)

**Measure:** Patient-rated Demographics measured with the baseline questionnaire on Demographics

**Time Frame:** Before start of radiation therapy

**Description:** Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)

**Measure:** Patient-rated symptoms measured with the EORTC QLQ-BR23

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated symptoms are measured with the Breast Cancer Questionnaire (BCSCQ: Based on the BCTOS (1) and the questionnaire on Patients' satisfaction with the cosmetic outcome by Sneeuw at al.(2))

**Measure:** Patient-rated symptoms measured with the BCSCQ

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years.

**Description:** Patient-rated symptoms are measured with the baseline questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases before start of radiation therapy (unvalidated questionnaire)

**Measure:** Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)

**Time Frame:** Before start of radiation therapy

**Description:** Patient-rated symptoms are measured with the follow up questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (semi)annually after last day of radiation therapy (unvalidated questionnaire)

**Measure:** Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)

**Time Frame:** 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)

**Measure:** Patient-rated symptoms measured with the questionnaire on Performance Status

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)

**Measure:** : Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor

**Time Frame:** 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)

**Measure:** Patient-rated Quality of Life measured with the EORTC QLQ-C30

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D_5L)

**Measure:** Patient-rated Quality of Life measured with the EuroQoL-5D_5L

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

**Description:** Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).

**Measure:** Patient-rated Quality of Life measured with EORTC QLQ-BR23

**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

#### Primary Outcomes

**Description:** Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

**Measure:** Score of Acute toxicity

**Time Frame:** Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.

**Description:** Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

**Measure:** Score of Late toxicity

**Time Frame:** At one and two years after last day of radiation therapy.

#### Secondary Outcomes

**Description:** Overall survival

**Measure:** Overall survival

**Time Frame:** At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

**Description:** Loco-regional tumor control

**Measure:** Loco-regional tumor control

**Time Frame:** At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria

**Gender Based:** True

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with breast cancer receiving radiotherapy

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Groningen

**Country:** Netherlands

**Facility:** University Medical Center Groningen

**Zip:** 9700RB

#### Overall Officials

**Official 1:**

**Affiliation:** UMCG

**Name:** Anne Crijns, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.

**PMID:** 11413515

**Citation:** Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.

**PMID:** 1470691

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
