## Protocol Section
### Identification Module
**NCT ID:** NCT05570279

**Acronym:** PLAN-A

**Brief Title:** PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark

**Official Title:** PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation

#### Organization Study ID Info
**ID:** KFE-1523
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-06

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-04-01

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-10-06
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-26
**Study First Submit QC Date:** 2022-10-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Herlev Hospital

**Class:** OTHER

**Name:** Vejle Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Aarhus University Hospital

#### Responsible Party

**Investigator Affiliation:** Aarhus University Hospital

**Investigator Full Name:** Karen-Lise Garm Spindler

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG).

Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome.

Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.

### Conditions Module

**Conditions:**

- Anal Cancer

### Design Module

#### Bio Spec

**Description:** Tissue from the primary tumor and pre-treatment and consecutive blood samples are collected for a prospective biomarker evaluation

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Rate of complete response to primary treatment as defined by clinical and radiological evaluation

**Measure:** Complete clinical response

**Time Frame:** 3 years

#### Secondary Outcomes

**Description:** The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.

**Measure:** Early toxicity evaluation by CTCAE

**Time Frame:** 2 weeks after the last day of therapy

**Description:** The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.

**Measure:** Late toxicity evaluation by CTCAE

**Time Frame:** 1 and 3 years post treatment

**Description:** European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaire (QLQ) C30 (core).

The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC (colorectal cancer) patients, which is designed to complement the EORTC QLQ-C30 questionnaire.

Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.

**Measure:** Quality of life assessed by the EORTC QoL questionaires

**Time Frame:** 2 weeks, 1 and 3 years post therapy

**Description:** Measurement of circulating tumor DNA (in copies per ML)

**Measure:** Prognostic value of ctDNA

**Time Frame:** At time of treatment completion, an average of 30 days, 1 and 3 years post therapy

**Description:** Frequency of pelvic insufficience fractures at MRI scans

**Measure:** Incidence of pelvis fractures

**Time Frame:** 1 and 3 years post therapy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥ 18
* Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
* Written and oral consent

Exclusion Criteria:

* Contraindication to blood sampling or MRI scans (substudy 1 and 2)
* Other malignant disease within 5 years except from basal cell carcinomas

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** k.g.spindler@rm.dk

**Name:** Karen-Lise G Spindler, DMSc, PhD

**Phone:** +4591167244

**Phone Ext:** +4591167244

**Role:** CONTACT

**Contact 2:**

**Email:** k.g.spindler@rm.dk

**Name:** Karen-Lise G Spindler, Professor

**Phone:** +4591167244

**Phone Ext:** +4591167244

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Aarhus University Hospital

**Status:** RECRUITING

**Zip:** 8000

**Location 2:**

**City:** Herlev

**Contacts:**

***Contact 1:***

- **Name:** Eva S Hansen

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Herlev Hospital

**Status:** RECRUITING

**Location 3:**

**City:** Vejle

**Country:** Denmark

**Facility:** Vejle Hospital

**Status:** RECRUITING

**Zip:** 7100

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000001004

- Term: Anus Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M4321

- Name: Anus Neoplasms

- Relevance: HIGH

- As Found: Anal Cancer

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4320

- Name: Anus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T362

- Name: Anal Cancer

- Relevance: HIGH

- As Found: Anal Cancer

### Condition Browse Module - Meshes

- ID: D000001005

- Term: Anus Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
